Regulatory Affairs Manager Resume Sample
Elise Powlowski
65462 Hollie Hills,
Philadelphia,
PA
+1 (555) 784 2631
Work Experience
Regulatory Affairs Manager
01/2018
-
PRESENT
Houston, TX
- Gain clear understanding of regulatory agency organizational structure, roles, responsibilities and current regulations. Monitor key issues, regulation changes and assess business implication
- Accountable for providing assessment of the impact of new and changing local regulations/requirements on the development of strategic and tactical plans
- Represent Shire in relevant national trade association regulatory working group
- Develop professional and effective working relationships with regulatory agencies
- Establish platforms for Shire to interact with regulatory authorities and enable their better mutual understanding
- Relevant regulatory experience
- Pharmaceutical or biopharmaceutical Industry experience
Senior Regulatory Affairs Manager
02/2014
-
12/2017
Chicago, IL
- Experience in diverse business roles – e.g., revenue generating roles, program management, audit/compliance, managing staff functions
- Qualitative assessment of registration work ( e.g. quality of PID and specification)
- HA relationship establishment
- Subordinates management and developmentRegulatory Affairs
- Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
- Prior experience in US, CE, and International Regulatory Affairs decision making
- Demonstrated human relation skills
- Regulatory Affairs Professional Society (RAPS) certification, management or supervisory experience
- Subordinates management and development
States Regulatory Affairs Manager
05/2009
-
09/2013
Chicago, IL
- Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements
- Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements
- Managing multiple activities
- Provide leadership and direction to the Americas regulatory team in the approach to product regulatory affairs
- Work with cross-functional teams to improve processes and workflows
- Develop sustaining relationships with internal and external customers to effectively communicate appropriate regulatory requirements and opportunities
- Ensure compliance with chemical product regulations in the Americas
- Manage the regulatory strategy for North and South America
Education
Western New England University
2004 - 2009
Bachelor's Degree in Pharmacy
Professional Skills
- Cross-discipline collaboration and teamwork: Ability to establish and nurture productive cross-functional stakeholder collaborations, to apply understanding of scientific & regulatory processes including internal and external relationships to advance company’s and technical organization’s priorities
- Skills: Strategic focus, Communication & Negotiation, Project management Skills, Coaching skills, Fluent written & spoken English
- Excellent verbal, written, presentation and organization skills; strong negotiation and proven ability to influence
- Effective negotiation skills with excellent interpersonal skills
- Strong multi-tasking, prioritizing and organizational skills required
- Very strong communication skills, Very strong networking/relationship
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
How to write Regulatory Affairs Manager Resume
Regulatory Affairs Manager role is responsible for interpersonal, english, regulatory, negotiation, organization, analytical, organizational, leadership, business, technical.
To write great resume for regulatory affairs manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Manager Resume
The section contact information is important in your regulatory affairs manager 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 Regulatory Affairs Manager Resume
The section work experience is an essential part of your regulatory affairs manager 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 regulatory affairs manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Manager resume experience can include:
- Strong verbal and written communication skills, documentation and analytical skills)
- Excellent business partnering skills and proven track record in supporting Sales team
- Demonstrated managerial skills, specially having a strong track record of success as a leader or agent of change and ability to lead multiple projects
- Excellent communication and proven negotiation skills
- Demonstrates excellent teamwork and communication skills with an ability to impact and influence the decisions of a team
- Effective project management skills and experience
Education on a Regulatory Affairs Manager Resume
Make sure to make education a priority on your regulatory affairs manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs manager 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 Regulatory Affairs Manager Resume
When listing skills on your regulatory affairs manager 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 regulatory affairs manager skills:
- Excellent communication skills, good in listening, good problem-solving and influential skills
- Excellent communication skill, both written and verbal, as well as good interpersonal, problem solving, and analytical skills
- Strong organizational skills, negotiating, and problem solving skills
- Project management skills, excellent oral & written communication skills, organization
- Developed project management skills including the use of Microsoft Project, Good Presenation and organization skills
- Communicate effectively to multiple levels of the organization with strong negotiation skills
List of Typical Experience For a Regulatory Affairs Manager Resume
1
Experience For Senior Regulatory Affairs Manager Resume
- Excellent interpersonal skills, demonstrated ability to work with others in international team environment
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Excellent time management skills, including project management
- Strong critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture
- Strong communication skills, including both written and oral
2
Experience For Associate Regulatory Affairs Manager Resume
- Effective management and team leadership skills
- Strong interpersonal and management skills with business acumen
- Excellent written and spoken communication skills in both French and English
- Good interpersonal , team work and project management skills
- Strong organization/planning skills and ability to coordinate and manage multiple projects and deadlines
- Excellent leadership skills, with the ability to make decisions which require extensive use of judgement
- Excellent Risk Assessment and Analytical skills
- Language skills: good English communication
- Cross-functional experience Knowledge and Skills
3
Experience For States Regulatory Affairs Manager Resume
- Experience in managing projects and a demonstrated ability to prioritise tasks to meet deadlines
- Detail oriented and good program management skills
- Strong knowledge of eCTD elements and structure and regulatory writing skills
- Strong communication, teamwork and conflict management and negotiation skills
- Strong communication skills and the confidence to influence and negotiate
- Excellent English language (written and oral) communication skills as well as local language where applicable
- Excellent analytical, investigative and problem-solving skills
- Good communications skills, including English and French fluency
- Proven sales experience within Lawn & Garden industry; 2+ years direct sales experience within grass seed and/or forage sales required
4
Experience For Regulatory Affairs Manager, Cardic Assays Resume
- Exhibit high attention to detail with excellent communication skills
- Excellent verbal and written communication skills in both local and English (written and spoken)
- Interdisciplinary thinking, and strong communication skills
- Excellent analytical and communication skills - both verbal and written
- Good skills with MS Word, Excel, PowerPoint, and Document Management Systems (ex. Veeva/Zinc, SharePoint, etc.)
- Outstanding communication, analytical, and organizational skills
- Analytical, attention to detail and problem-solving skills including decision-making for operational issues
- Good communication skill and getting along with people at all levels
- Regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical / industry experience
5
Experience For Scientific & Regulatory Affairs Manager Resume
- Communicates effectively in verbal presentations and in writing strategy plans
- Prior experience working in international organizations
- Prior work experience directly involving regulatory attorneys, Customer Service, Rates and Energy Delivery is beneficial
- Prior experience supporting cross-functional product development and/or launch teams for Crop Protection products and/or Seed Applied Solutions
- Auditing experience or equivalent combination of experience and education
- Advanced technical writing skills and acute attention to detail
- Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
- Regulatory affairs CMC experience (or relevant experience), preferably in Phase 3 or commercialized products
- Analytical and problem solving skills, hands-on mindset
6
Experience For Regulatory Affairs Manager, Asia Resume
- Demonstrated ability to coordinate and prioritize workload in collaboration with cross-functional colleagues
- Review submissions of regulatory staff and coach to ensure continuing development of regulatory skills
- Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and audits
- Demonstrated scientific and/or medical writing experience
- Establish & operate an effective monitoring network to identify opportunities and threats within the legislative and regulatory processes
- Solid experience in the area of regulatory or managing complex process
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Then,
7
Experience For Global Regulatory Affairs Manager Resume
- The ability to effectively manage projects and relationships with local partners, contractors, and consultants to achieve Reckitt Benckiser’s objectives
- Experience : 2-3 years with experience in Pharmaceutical Regulatory
- Proactively manage local healthcare issues & ensure best practices are communicated and escalated effectively
- Experience in relevant Regulatory Affairs experience
- Min 3 years related experience with a medical manufacturer or equivalent combination of education and experience
- Work effectively with a wide range of professional adversaries in regulatory proceedings
- Project managements skills is an advantage
- Relevant experience of a team environment to ensure effective contribution and commitment of staff
8
Experience For Quality Assurance & Regulatory Affairs Manager Resume
- Work in a matrix organization and participate effectively both independatly and as part of multiple teams
- 'Several years (> 3 years for ) of prior experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
- Work effectively in multicultural teams and to work across a broad range of audiences
- Great communication skills and the confidence to influence and negotiate
- Solid experience in a Food Regulatory environment; or IMF category environment (preferably in infant formula)
- Has thorough experience with CMC Regulatory requirements of final dose forms; particularly: solid oral, parenteral and ophthalmic
9
Experience For Regulatory Affairs Manager, Usona Inst Resume
- Superb relationship management skills are required in order to influence cross functionally and with external third parties
- Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of products
- Apply knowledge of key global guidance documents, regulations, or directives and effectively communicate any impact on Array's development programs
- Act as company representative with governmental agencies to make registration problems encountered be effectively resolved
- Present to upper management at required intervals and effectively communicate successes and challenges
- Structured approach as well as capacity for teamwork, outstanding communication, negotiation and organisational skills are also very welcome
10
Experience For Scientific Regulatory Affairs Manager Resume
- Effectively work in a team environment and develop peer relationships
- Managing existing and future regulations and standards so that they are implemented into ResMed’s products in an effective and timely manner
- Ensuring strong relationship with the industry associations, regulatory agencies and with external stakeholders
- Working knowledge of International Device/Biologics/Drug regulations with specific experience with Medical Device regulatory submissions
- Emerging Market regulatory affairs "hands on" experience with PM is mandatory
- Planning, prioritization and resources management of Regulatory activities and projects to best meet the needs of the Local Operating Company
List of Typical Skills For a Regulatory Affairs Manager Resume
1
Skills For Senior Regulatory Affairs Manager Resume
- Excellent organizational skills with attention to detail and written and oral communication skills
- Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently
- Strong skills in planning, organizing, decision-making and problem-solving
- Strong analytical, planning, organizing and problem solving skills
- Good organizational and planning skills, ability to communicate well verbally and in writing
2
Skills For Associate Regulatory Affairs Manager Resume
- Strong leadership with ability to manage working group and having good communication skill
- Strong computer skills, including word processing, Excel, database/document repository and project management software
- Strong interpersonal skills, allowing direct reports to approach the RA Manager, and collaborate on the resolution of issues within their work location
- Strong scientific analytical and writing skills, proficient in MS Word, MS Powerpoint and MS Excel software
- Demonstrated analytical and creative thinking skills and the ability to solve complex problems
3
Skills For States Regulatory Affairs Manager Resume
- Good interpersonal, organizational, problem solving and leadership skills
- Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts
- Excellent communication skills both written and verbal and ability to present complex technical information in succinct and high level briefing style
- Management, leadership and mentoring skills and experience
- Have excellent problem solving skills and uses data to connect multiple ideas and develop solutions
- Diplomatic, strong listening and analytical skills
- Strong team skills and comfort working in a matrix-managed environment
- Excellent influential communication skills, over the telephone, in person, and in writing
4
Skills For Regulatory Affairs Manager, Cardic Assays Resume
- Systematic and discerning ability to handle priorities effectively
- Good IT knowledge and proficient in computer skills, including MS Office
- Strong leadership skills, including the ability to meet/ exceed goals to positively impact business results
- Strong organizational skills, especially in the creation and maintenance of product dossiers and filing systems for Latin America
- People development experience and mentoring skills
5
Skills For Scientific & Regulatory Affairs Manager Resume
- Strong interpersonal and influencing skills are required
- Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements
- Very good administrative skills and be able to handle large volumes of documents
- Strong team-working skills – working across cultural and functional boundaries, and leading ‘virtual teams’
- Excellent analytical and problem solving skills; scientific and/or technical knowledge pertaining to pharmaceutical development or operations
6
Skills For Regulatory Affairs Manager, Asia Resume
- Strong intercultural and problem solving skills
- Strong and credible communications skills, be comfortable with multitasking with high predictability and a global team player
- Good communication, negotiation and organizational skills
- Leveraging the team’s collective knowledge, skills and expertise to produce credible, high quality outputs, including written and oral briefings
- Persuading, influencing and negotiation skills
- Good English skill in listening, writing, and speaking
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Responsible for mentoring and developing the professional skills of Regulatory Affairs employees
- Strategic thinker, creative problem solving, analysis, investigative, risk mitigation and decision making skills required
7
Skills For Global Regulatory Affairs Manager Resume
- Experience with least one major marketing application or extensive experience with late stage development
- Effectively communicate with project/product teams; liaise with data generating departments and Health Authorities as required
- Good understanding of the pharmaceutical industry and regulatory experience in drug
- Significant experience in the Pharmaceutical Industry, including experience within EU or UK Regulatory Affairs
- Project management skills with ability to work well with others in demanding situations
- Exceptional attention to detail and well-developed analytical thinking skills
8
Skills For Quality Assurance & Regulatory Affairs Manager Resume
- Ensure direct reports receive appropriate training in the area of expertise and functional skills
- Ensure training and development for end users on all healthcare regulatory related knowledge, skills and responsibilities
- Excellent project management skill (planning, collaboration/coordination, execution)
- Regulatory Experience, medicinal regulatory affairs experience working on OTC/consumer products in at least one geography, especially such as EU or Asia
- Proven experience in receiving regulatory approval for medical device submissions
- Interpersonal skills and multitasking
9
Skills For Regulatory Affairs Manager, Usona Inst Resume
- CMC-specific regulatory knowledge & experience with solid working knowledge of Clinical Trial Disclosure (CTD)
- Computer skills, including proficiency with Microsoft Word, Excel, PowerPoint and Project are required
- Interpersonal skills and operational understanding to manage the sub-regional regulatory team
- Communication skills – both oral and written
- Communication skills in English (TOEIC score ≥780, desirable)
10
Skills For Scientific Regulatory Affairs Manager Resume
- Demonstrated knowledge and experience in monitoring regulation and policy and aligning to business impact
- Investigation / Interviewing skills
- Exceptional collaboration and teamwork skills. Comfortable in working in a matrix organization with multiple partners, stakeholders and customers
- Interpersonal skills to work with and support the senior management Team
- A solid track record of Regulatory management experience and knowledge in NPD and dossier/technical file creation and global registrations
- Work related experience in quality management system/regulatory affairs experience in the medical or consumer device industry
- Analytical skills: accuracy, reliability, attention to detail
List of Typical Responsibilities For a Regulatory Affairs Manager Resume
1
Responsibilities For Senior Regulatory Affairs Manager Resume
- Excellent Office Suite skills, including PowerPoint presentations, Word and Excel
- Effective negotiation, mitigation and problem-solving skills
- Excellent analytical, interpretive and interpersonal skills
- Fluent in English language and excellent communication skills
- Good interpersonal and organizational skills, ability to work in an international team environment
- Demonstration of effective written and oral communication skills
- Excellent verbal and written, communication and negotiation skills
- Excellent business acumen, superior organizational and analytical skills
2
Responsibilities For Associate Regulatory Affairs Manager Resume
- Self-starter who is able to work across functions, regions and with excellent communication skills
- Demonstrated experience of managing multiple franchise projects simultaneously and consisting of varying degrees of complexity
- Practical experience in handling European and/or US registration procedures and solid regulatory understanding
- Trade associations: Understanding of key trade associations and global regulatory policy landscape affecting food and beverage industry Functional Skills
- Ensure direct reports receive appropriate training in the Regulatory Affairs environment and functional skills
- A proven track record of delivering strong and sustained control and operational performance
- Strong record of related experience within Regulatory Affairs
- Professional experience in medical device, biotech, or clinical industry with at least 3+ years of experience in Regulatory Affairs
3
Responsibilities For States Regulatory Affairs Manager Resume
- Effectively manage the Regulatory Affairs team to ensure on-time submissions and approvals. Develop and retain talent
- Experience in the pharmaceutical industry including development experience with biologics
- Quickly learns when faced with new challenges and strives to enhance his / her knowledge and skills. (Success Factor: Drives Innovation and Growth)
- Strong experience working in regulated medical device, biologics, or cell therapy industry
- Hands-on RA experience with good understanding of local registration requirements and the related safety issues
- Experience managing a team and experience in developing and coaching employees
- Related experience in a pharmaceutical environment or equivalent combination of experience and education
- Experience in reading, understanding, and applying promotional regulations to a constantly changing environment
- Experience in developing and reviewing as well assuring required compliance of design control and associating technical documentation
4
Responsibilities For Regulatory Affairs Manager, Cardic Assays Resume
- Experience preparing, reviewing, and filing U.S. medical device regulatory submissions, including 510(k)s, PMAs, and Q-submission filings
- Skilled at developing positive working relationship and influencing others
- Experience in preparing, supporting notified body audits including technical file and QMS audits and FDA inspections is an advantage
- Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures
- Provides people leadership to direct reports, including goal setting, prioritization, mentoring, professional development and performance management
- International organizations: Experience in international food standard setting processes and reviewing and analyzing proposed standards
- Thorough understanding of and experience working with chemical regulations such as GHS, REACH, and TSCA
- Consistent proactive & interpreting attitude towards clients’ issues and track record of being a strong team player
- Experience and direct involvement in securing licences, or re-licensing and consents in the UK nuclear industry
5
Responsibilities For Scientific & Regulatory Affairs Manager Resume
- Direct experience with generating CTA and MAA documentation for EU and emerging markets
- Proven expertise in understanding the FDA, Europe and global regulatory requirements and executing successful regulatory submissions
- Experience working in multi-national companies or service industry in MNC setting
- Experience understanding and interpreting data/information and its practical application
- Experience of devising regulatory strategies and conducting assessments for CE/US markets is required
- Experience of analyzing and applying harmonized medical device standards
- Experience in medical device industry operating according to US or EU regulation
6
Responsibilities For Regulatory Affairs Manager, Asia Resume
- Responsible for ensuring compliance with the current IS regulatory procedures and updating the procedures when new regulatory requirements become effective
- Leads in engaging regional and global SRA teams to ensure effective delivery of scientific learning in health & nutrition, food safety and sustainability
- Assume ownership, operate and manage various database and reporting systems to ensure proper record keeping
- In depth Knowledge of electronic filings processes and procedures and experience applying critical overview and critique to ANDA filing package
- Demonstrated success working in a multi-faceted matrix environment and leading without formal authority
- Excellent understanding of local and EU legislation, procedures and guidelines governing pharmaceutical products
- Good understanding of the structure, functions and operating procedures of China HA
- Proven understanding of clinical research guidelines including GCP,GMP,GLP and Chinese GCP
- Excellent working knowledge of medical device regulations MDD/MDR/CE marking
7
Responsibilities For Global Regulatory Affairs Manager Resume
- Demonstrable experience working regulatory submissions and providing guidance and direction throughout the product life cycle
- Experience at formulating and implementing successful regulatory strategies
- Experience in Regulatory Affairs, Quality, R&D, Manufacturing, Scientific Affairs or related area, including 3-5 years in Regulatory Affairs
- Experience in manufacture, testing (QC/QA or Clinical), or distribution in Biotech/Pharma industry
- Demonstrated success in working with teams across functions and regions
- Good knowledge and understanding of the drug development process in general
- Extensive experience in working across a wide range of regulatory systems and databases (5 years)
8
Responsibilities For Quality Assurance & Regulatory Affairs Manager Resume
- Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to obtain valid artworks and implementation dates
- Regulatory experience from industry and/or authorities supported by a robust business understanding
- Demonstrated ability to deal with rapid change, sound judgment and flexible approaches to managing situations
- Experience of working in a Regulatory role with the pharmaceutical industry, preferably within animal health
- Experience working remotely with in-country representatives and with USA-based headquarters
- Prior success managing multiple projects simultaneously in a fast-paced environment
- Assess risk and develop risk mitigation strategies within the regulatory environment while balancing business strategic priorities
- Successful experience taking a product through the development and regulatory cycle both domestically and internationally is desired
9
Responsibilities For Regulatory Affairs Manager, Usona Inst Resume
- Project / people management experience in regulatory/quality system / engineering medical device environment
- Validate product labeling
- Experience in Multi-tasking in a deadline controlled and highly regulated environment
- Direct experience working within regulatory affairs for NHP, OTC, DIN, medicinal products and/or devices or cosmetics with Health Canada
- Strong business acumen and marketing savvy
- Extensive experience working in ICH/GCP environment
- Clinical Research Setting Experience Ideal
- Experience preparing 510(k) submissions for medical devices is required
10
Responsibilities For Scientific Regulatory Affairs Manager Resume
- Advanced experience with assembling global dossiers
- Experience in handling issues resolution in regulatory affairs
- Previous experience registering medical devices in Europe, Asia, and Latin America
- Experience interacting with CDRH
- Experience in preparation, submission of US regulatory files (510(k)s, PMAs) and interface with FDA during review process is an advantage
- Experience of working in a virtual team and/or global organization would be an asset
- Post marketing regulatory experience
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