Director, Regulatory Affairs Resume Sample
Graham Mohr
28563 Spencer Stravenue,
Boston,
MA
+1 (555) 429 1906
Work Experience
Director, Regulatory Affairs
03/2017
-
PRESENT
Detroit, MI
- RAC Certification desirable
- Read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence, and clearly and succinctly convey written communication. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization
- Combine knowledge of scientific, regulatory and business issues to enable Abbott
- Develop and supervise regulatory professionals
- Have division level influence and be generally considered a key opinion leader and an expert resource both within Abbott and externally
- Anticipate emerging regulatory issues and develop solutions
- Plan, direct, coordinate and control the regulatory affairs activities related to products worldwide
- Create and develop product positioning strategies based upon regulatory requirements
Director Regulatory Affairs
10/2010
-
12/2016
Philadelphia, PA
- Integrate regulatory considerations into the corporation’s global product entry and exit strategy
- Effectively communicate, prepare, and negotiate internally and externally with
- Create mid- to long-range plans to carry out objectives established by top management
- Develop and calculate a budget for one or more departments to meet organizational goals; Forecast future departmental or group needs including human and material resources and capital expenditures
- Determine and establish organizational structure and supervisory relationships subject to top management approval
- Timeline Preparation and Conformance: Working in collaboration with the VP, Regulatory/Quality Affairs, Corporate QRM and other departments prepare and manage regulatory submission and approval timelines consistent with companywide goals/objectives and insure that all necessary documents are submitted in a timely fashion to external organizations
- Budget Management: Manage regulatory activities within annual budget for the Regulatory department
- External Interactions: Interact frequently and maintain good relations with national regulatory agencies (FDA etc) in the US and abroad
Executive Director, Regulatory Affairs
07/2008
-
09/2010
Chicago, IL
- Regulatory Strategy: Develop and implement regulatory strategies for a new Class Ill device through interface with FDA, International Regulatory Agencies, physicians, consultants, and internal team members
- Regulatory Approvals: In conjunction with R&D, Quality, Pre-Clinical and Clinical, prepare or direct the generation of applications for conducting clinical investigations and product approvals in U.S. and OUS
- Regulatory Compliance: Ensure compliance with relevant FDA and International regulations and guidelines, including MOD, 51O (k), IDE, PMM, GMP, MDR/Vigilance reporting, and labeling/advertising
- Regulatory Procedures: Ensure compliance with departmental and corporate regulatory affairs policies and procedures
- Experience with international medical device submissions required
- Experience in the Medical Device field for 10 years or more, with managerial leadership for 5 years or more
- Experience with Clinical Trial applications (US IDE) required
Education
Utah State University Eastern - Price Campus
2002 - 2007
Bachelor's Degree in Science
Professional Skills
- Excellent skills in oral and written communication, including effective presentation skills to clearly articulates ideas, opinions and information
- Excellent oral communication skills and high level of comfort and experience presenting to with executive leaders and regulatory agencies
- Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired
- Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting in order to execute on-time
- Demonstrate strong teambuilding skills
- Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products
- Excellent interpersonal skills and ability to communicate effectively across Global Regulatory Affairs and across the different organization functions
How to write Director, Regulatory Affairs Resume
Director, Regulatory Affairs role is responsible for leadership, interpersonal, regulatory, negotiation, organization, organizational, record, computer, technical, influencing.
To write great resume for director, regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Regulatory Affairs Resume
The section contact information is important in your director, regulatory affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, Regulatory Affairs Resume
The section work experience is an essential part of your director, regulatory affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, regulatory affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Regulatory Affairs resume experience can include:
- Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities
- Strong negotiation skills and significant experience in interacting with regulatory authorities
- Strong verbal, written and interpersonal communication skills, including effective negotiation techniques
- Quickly adapt to changes in business priorities and effectively manage competing business priorities
- Manage assess and prioritize multiple complex problems/projects by exercising independent decision making and analytical thinking skills
- Brings a demonstrated track record of setting up and growing successful regulatory groups in the US and deep domain expertise and BD skills
Education on a Director, Regulatory Affairs Resume
Make sure to make education a priority on your director, regulatory affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, regulatory affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, Regulatory Affairs Resume
When listing skills on your director, regulatory affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, regulatory affairs skills:
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
- Strong interpersonal skills and the ability to deal effectively with a variety of staff including commercial, medical, scientific and manufacturing staff
- Experience building and/or leading teams; strong leadership skills
- Strong leadership skills with a proven track record of building high performing teams and talent development
- Proven 3-5 years in a leadership role with strong management skills
- Possess advanced leadership skills, business acumen and ability to effectively execute against change management strategies and plans
List of Typical Experience For a Director, Regulatory Affairs Resume
1
Experience For Director Regulatory Affairs Resume
- Excellent oral and written communication, technical writing and editing skills are required
- Excellent strategic thinking, analytical, written and oral communication skills
- Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc
- Excellent organizational, planning, and follow-up skills
- Excellent verbal, written skills
- Work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
- Proven track record of building solid relationships with policy makers; external and internal stakeholders within organizations related to the telecom industry
- Extensive experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a health authority
- Experience in a broad scope of functions, including CMC and clinical operations and/or project management is strongly desirable
2
Experience For Assoc Director, Regulatory Affairs Resume
- Demonstrated experience driving change initiative projects
- Working knowledge or experience with vendor management
- Experience leading, developing and implementing clinical complex regulatory strategy
- Experience in managing major regulatory filing(s) such as IND or NDA marketing applications
- Demonstrate a sense of urgency; understand the importance of outperforming and outpacing the competition in meeting customer and patient needs
3
Experience For Executive Director, Regulatory Affairs Resume
- Demonstrated leadership success in management, including leading a team of regulatory affaris professionals
- Experience in preparing/reviewing regulatory IND/CTA and NDA/MAA submissions and eCTD preparation
- Experience working with contract research and manufacturing organizations
- Ability to work on a number of competing deadlines and conflicting priorities
- Skilled at gathering supportive information and developing product approval strategies
- Proven track record of successfully interacting and negotiating with regulatory health authorities
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
- CRO/Consulting and customer facing experience is desirable
4
Experience For Senior Director Regulatory Affairs Resume
- Experience in the design and delivery of safety and environmental training programs
- 15+ years relevant industry experience in regulatory environment with increasing responsibilities
- Strong understanding of medical, clinical, and regulatory issues related to device requirements
- BLA/CTD marketing submission experience required
- Experience in managing direct reports is required
- Experience working in a complex and matrix environment, and with multiple stakeholders
- Experience managing a large team
- Relevant work experience in Regulatory Affairs, policy analysis, or lobbying
- A thorough working experience in a regulatory affairs department with knowledge of FDA divisions, personnel, and procedural concepts
5
Experience For Director, Regulatory Affairs EU / Eemea Resume
- Food Science, Nutrition and/or food processing experience and knowledge required
- Experience working with PLM, QMS and certificate management systems
- Experience developing scorecards, KPIs and other business reports
- Previous supervisory experience managing multiple levels of direct reports is required
- Research laboratory, process development or manufacturing experience with biotechnology products highly
6
Experience For Director Regulatory Affairs Strategy Resume
- Breadth of regulatory experience to solve complex problems involving a number of different scientific specialties
- Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams
- Proven success in agency influencing and negotiation
- Good understanding and use of technology, particularly web enabled systems
- Demonstrated aptitude for managing projects and teams
- Evidence of successful submissions to FDA and EMA (e.g., IND, NDA, MAA, briefing packages)
- Experience with at least one e-publishing software
- Five or more years of progressively responsible experience working with higher education regulations and compliance on a nationwide basis
- Strong attitude to set a vision for an organization, develop according strategies and mobilize employees to achieve their objectives
7
Experience For Associate Deputy Director, Regulatory Affairs Resume
- Experience interfacing with relevant regulatory agencies
- Experience in interpretation of regulations, guidelines, policy statement related to product labeling, promotions and other communications
- Experience working with state and national organizations in higher education
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans
- Experience at filing strategy development as well as negotiation strategy with agency
- Strong understanding of industry trends as well as Regulatory paths for Companion Diagnostics in vitro diagnostics in US, Europe, Japan and other major markets
8
Experience For Director, Regulatory Affairs Strategy Resume
- Experience with preparing submission-ready PDFs
- Experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations
- Good working knowledge of regulations and guidelines related to drug development and registration is required
- Global drug development and regulatory affairs experience in the CRO, Biotechnology or Pharmaceutical industries
- Thorough knowledge and direct experience with the 510(k) and PMA submission process and FDA regulations
- Demonstrated specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional
- Industry experience in IVD/ medical device area, with 5+ years in a Regulatory Affairs position
9
Experience For Director, Regulatory Affairs & Compliance Resume
- Providing inputs into the regional Portfolio planning activities
- Ensuring support of Global Regulatory Team (GRTs) and managing resources
- Keeping up with US and global regulatory requirements and guidance, and providing oversight and review of key regulatory documents
- Including medical device submissions and clinical trials
- Maintaining confidentiality of work‐related information and materials
10
Experience For Executive Director, Regulatory Affairs CMC Resume
- Working with regional staff, assemble the global regulatory plans for identified projects/products
- Labeling · Controlled substances (e.g. DEA)
- Advising the regional regulatory leads on regulatory agency considerations in strategy development
- Ensuring regional regulatory needs are well defined and implemented
- Working with internal QA, participate in the development, design and implementation of a QSR system at Q2 Solutions
- Understanding of initiatives under Medicare such as MIPs, APMs, and bundled payment models
List of Typical Skills For a Director, Regulatory Affairs Resume
1
Skills For Director Regulatory Affairs Resume
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
- Strong leadership and communication skills and experience in working with multiple functional areas
- Outstanding written communication skills with experience in authoring both internal and externally facing regulatory related documents
- Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously
- Demonstrated leadership skills in building a team within the RA function
- Excellent communication, collaboration and influencing skills at all levels of the organization
- Excellent verbal and written communication and skills
2
Skills For Assoc Director, Regulatory Affairs Resume
- Strong communication and proactive negotiation skills
- Sound leadership skills and demonstrated ability to guide projects to successful conclusions
- Excellent organizational, leadership, interpersonal and influencing skills
- Excellent communications skills at all levels - both internally and externally
- Evidence of successful submissions to FDA (e.g., 510(k)s, PMAs, pre-submissions) and demonstrated evidence of writing of regulatory documents
- Strong interpersonal skills including verbal and written communication
- Good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner
- Strong team player with outstanding, interpersonal, written and oral communication skills in at least English
3
Skills For Executive Director, Regulatory Affairs Resume
- Developed marketing skills: demonstrated ability to interact with clients and manage client relations, develop strategies
- Demonstrated ability to effectively lead, coach and mentor colleagues
- Lead talent management and guide personal development activities for the team to grow knowledge, skills and experience of team members
- Excellent interpersonal and communication skills; ability to lead a team and work as a team member within a fast pace global interdisciplinary team
- Proven ability to effectively work on inter-disciplinary and cross functional teams
- Strong oral and written communication skills, including ability to articulate regulatory position
- Prior experience and success with filing NDAs/MAAs. Experience with both early and late stage drug development as well as Lifecyle management
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
- Outstanding analytical skills to work on extremely complex problems where analysis of situations or data requires and evaluation of intangible variables
4
Skills For Senior Director Regulatory Affairs Resume
- Working effectively with a diverse and multi‐cultural student body and staff
- Outstanding collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment
- Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable
- Skilled in establishing and maintaining the effective working relationship with internal and external constituents
- Highly developed written and oral communication, technical writing and editing skills
- Demonstrated evidence of writing regulatory documents (Module 1, Module 2, briefing packages)
- Pharmaceutical industry experience, including 5-7 years in Regulatory Affairs. Global experience desired
- Experience in compliance group including 2+ years of managerial experience
- Proven experience in business development activities and networking
5
Skills For Director, Regulatory Affairs EU / Eemea Resume
- Capable of effectively acting as a liaison with other departments
- Five years related work experience including managerial experience
- Ten or more years related work experience including managerial experience
- Demonstrated evidence of writing of CMC regulatory documents
- Demonstrated ability to resolve conflicts with a successful record of supervisory or team leadership experience in a demanding work environment
- Effectively negotiate regulatory agreements with global regulatory agencies
6
Skills For Director Regulatory Affairs Strategy Resume
- Line management experience required, with demonstrated success in development, engagement and performance of senior staff
- Communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
- Possess the ability to communicate effectively with both customers and industry thought leaders
- Greater than 10 years work related profession experience. 7 years experience in drug/diagnostic regulatory affairs
- Effectively manage the Regulatory Affairs team to ensure on-time submissions and approvals that support the mitral and tricuspid therapies initiatives
- Strong experience preparing regulatory submissions for development products
- Proven track record in establishing effective regulatory interactions
7
Skills For Associate Deputy Director, Regulatory Affairs Resume
- Experience in regulatory affairs including both US FDA and International experience in Medical Devices or OTC Drugs
- Lead/Operate with strong global teamwork with the Regulatory Matrix Team and Medicine Development Team
- Strong background and experience in supervising a large team of Regulatory professionals
- Greater than ten years’ experience in the medical products industry or relevant medical device experience as needed for the position
- Prior drug development experience
- Manage projects and client relationships cost-effectively
8
Skills For Director, Regulatory Affairs Strategy Resume
- Effectively represent Regulatory Affairs within a collaborative cross-functional team that includes Legal, Medical Affairs, and Commercial colleagues
- Providing country input to developing and executing regulatory strategies and effective key regulatory agency interactions
- Planning, prioritizing, and problem‐solving
- Leading and providing direction for effective prosecution of the developed regulatory strategies including FDA advisory committee meetings
- Working experience with leading FDA NDA/BLA/IND submissions
- Experienced leading, training and developing regulatory staff
- Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership
- Experience of working with / overseeing contract manufacturing organizations from a regulatory or quality perspective
9
Skills For Director, Regulatory Affairs & Compliance Resume
- Experience with supporting early development projects, including filing of at least one new IND submission
- Ensure effective department procedures, including developing and reviewing SOPs, as well as provide guidance for other functional areas SOPs
- Evidence of being highly team oriented, collaborative and adept at developing trusting relationships with stakeholders
- Demonstrated leadership success in management, including building and/or leading a regulatory affairs team
- Experience and knowledge in preparation of regulatory submissions including but not limited to INDs, IMPDs, meeting requests, and briefing books
10
Skills For Executive Director, Regulatory Affairs CMC Resume
- Strong competency in understanding regulatory requirements and emerging regulatory landscape
- Experienced in providing strategic regulatory input for global development and creating Regulatory Strategic and tactical plans (RSTPs) for the same
- In pharmaceutical industry regulatory affairs, including experience in leading regulatory teams
- Excellent knowledge of Global Regulatory Procedures, including both clinical trials and product licensing
- Experience conducting investigations at client sites and creating evaluations of those findings
- Experience of working at a Pharmaceutical Manufacturing site in a Regulatory, Quality or Technical Role
- Experience of working in a regional or global capacity, managing direct reports remotely. Proficiency in Spanish and / or Portuguese would be an advantage
- Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
- Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission
List of Typical Responsibilities For a Director, Regulatory Affairs Resume
1
Responsibilities For Director Regulatory Affairs Resume
- Develop and implement an overall government affairs strategy for South Asia in close coordination with the VP Government Relations Asia Pacific, the South Asia Group Country Manager and other Visa business leaders to achieve agreed objectives
- Excellent and proven, leadership and line management skills
- Strong coaching skills and ability to do so at all levels of the organization
- Demonstrated superior communication skills in multicultural environment and the ability to communicate complex issues in a succinct and logical manner
- Attention to detail and strong organizational skills with ability to meet multiple deadlines
- Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years’)
- Advanced leadership skills and line management experience
2
Responsibilities For Assoc Director, Regulatory Affairs Resume
- Strong people management skills in regulatory
- 7) Excellent verbal and written communication, as well as interpersonal, skills are required
- Negotiation skills and strong project management capabilities
- Excellent written and oral communication skills are imperative
- Communicate effectively within the organization and with internal/external customers regarding regulatory and product related activities
- Exceptional client relationship-building skills
- Effectively lead and manage multiple time-sensitive projects
- Assesses priorities and makes assignments to team members to assure project and company priorities are met
- Effectively communicate complex information and analyses to a variety of audiences, in both verbal and written format
3
Responsibilities For Executive Director, Regulatory Affairs Resume
- Prior experience in several areas within regulatory affairs
- An assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done
- Strong Regulatory management experience
- 6) Prior managerial experience, with direct supervision of senior level regulatory professionals, is highly desirable
- In pharmaceutical industry Regulatory Affairs, including experience in leading Regulatory teams
- Possesses strong scientific and technical expertise, including the ability to develop robust global regulatory plans covering all phases of drug development
4
Responsibilities For Senior Director Regulatory Affairs Resume
- Provide strong leadership while engendering trust and exhibiting excellence in transparency
- Fosters positive and effective working relationships between project team members and health authority reviewers
- Experience with all types of submissions, including INDs, NDAs, eCTD, A/NDA, CMC, or other agency submissions and familiarity with associated regulations
- Experience in developing drug master files or site reference files
- Regional labeling, and effective regulatory agency interactions
- Research laboratory, process development or manufacturing experience with biotechnology products highly desirable
- Experience in working management positions, responsible for regulatory compliance in the controlled substances space
- Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages)
- Develop and maintain effective working relationships with employees and external business contacts
5
Responsibilities For Director, Regulatory Affairs EU / Eemea Resume
- Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA briefing packages)
- Regulatory experience supporting development projects
- Results oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion
- Deep and broad knowledge of regulatory affairs strategy ; direct experience with pharmaceutical regulatory submissions and product approvals worldwide
- Strong knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling
- Demonstrated success in constructive contribution and regulatory leadership in a multi-disciplinary team environment
- Experience in formulating health care policy
- Experience working within a matrix environment is desirable
- Pharma/biotech industry experience
6
Responsibilities For Director Regulatory Affairs Strategy Resume
- Relevant experience in the energy industry
- Prior staff management of several personnel
- Demonstrated competency in leadership and management
- Relevant pharmaceutical industry and regulatory experience
- Pharmaceutical industry and 10+ relevant regulatory CMC experience
- Demonstrated ability to lead teams by influence
- Experience or regulatory affairs
- 2) BS/MS requires 10 years relevant experience in Regulatory Affairs
7
Responsibilities For Associate Deputy Director, Regulatory Affairs Resume
- Solid knowledge of GCPs and GLPs
- Guide, train, supervise and prioritize workload of direct reports if applicable
- Experience in the interpretation of regulations, guidelines, policy statements , etc
- Knowledge of Regulatory Affairs with diverse experience in regulated industry (Device, Pharma, Personal Care or Food)
- Experience in the interpretation of regulations, guidelines, policy statements, etc
- Direct experience with regulatory agencies
- Regulatory experience
- Strong regulatory strategy background and full understand of end to end drug development process
8
Responsibilities For Director, Regulatory Affairs Strategy Resume
- Eight to ten years of managerial experience in Regulatory Affairs activities, or related field
- Experienced in FDA QSR requirements and ISO-13485 requirements
- Experienced in US and international regulatory filings
- Recent Oncology experience
- Experience working in a cross-functional team environment for new product development
- Project management experience, knowledge of product development and the QSRs for medical devices
- Work related professional experience in in vitro diagnostic, medical devices and life sciences
- Experience in diagnostic regulatory affairs
9
Responsibilities For Director, Regulatory Affairs & Compliance Resume
- Organizing and maintaining team communications including: meeting agendas, minutes, task lists, and risk analyses/mitigation strategies
- Understanding of the process of development and marketing of a device or drug/device combination including
- Working knowledge of the drug/biologic development process, including clinical trial design and labeling development
- Identifying and documenting team and sub-teams' memberships
- Identifying risks to project objectives and escalating, as defined in the escalation path, to Project Leadership in a timely manner
- Leading and developing Regulatory staff to become future leaders
- Representing regulatory on the product teams and other key commercialization governance bodies, including the Business Unit Enterprise Boards
- Managing overall cross-functional and mulit-purpose timelines
- Leading the identificationof the escalation path for issue resolution
10
Responsibilities For Executive Director, Regulatory Affairs CMC Resume
- Defining the strategic regulatory direction for pipeline development and global launch excellence for a significant global platform with dedicated R&D budget
- Having an eye for detail is required
- Labeling review and submission to FDA
- Providing regulatory strategy and submission deliverable plans for assigned devices or drug/device combinations
- Leading regulatory team(s)
- Working knowledge of eCTD structure
- Ensuring that the regulatory affairs staff in Russia & CIS delivers on local regulatory strategies and goals across their country
- Representing regulatory affairs on country management team
- Understanding of the requirements of successful consultancy
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