Regulatory Manager Resume Sample
Stephania Bruen
862 Colten Camp,
Boston,
MA
+1 (555) 141 6655
Work Experience
Regulatory Manager
05/2017
-
PRESENT
San Francisco, CA
- Be the regulatory expert for TR China, monitor and track regulatory changes/updates particularly focus on China market information, foresee potential risks if any, and provide function support/possible solutions to internal stakeholders, including Sales team, marketing team, DC team, HR and etc.
- Actively participate in and work with trade organizations to build relationships, broaden understandings, and further cooperation
- Work with Flavor Extract Manufacturer’s Association (FEMA) staff on flavor issues of importance to the Company and the industry
- Manage and oversee the process of documenting and disseminating regulatory and corporate policy training requirements to all SC associates, including executive management, on a broad spectrum of topics including, but not limited to
- Travel to different SC sites, if needed
- Frequently in an office environment
- Occasionally exposed to work in high, precarious places
- Occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals
- Occasionally exposed to outdoor weather conditions; extreme cold; extreme heat
Senior Regulatory Manager
07/2010
-
03/2017
Boston, MA
- Occasionally exposed to moving mechanical parts, hand tools and small to medium-sized power tool use
- Occasionally exposed to non-toxic propane fumes or airborne particles
- Occasionally exposed to toxic or caustic chemicals
- Directs the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports
- MSc or equivalent in science (biotechnology, biology, microbiology, agricultural science, veterinary science or related field)
- Several years of RA experience from relevant industry or authority, most preferably in the AH&N or veterinary area
- Solid understanding of the regulatory aspects surrounding the approval of vaccines and pharmaceutical drugs, and feed ingredients
- Work at a strategic level and to translate legislation into company product related requirements
Regulatory Manager, Flavors Group
03/2004
-
02/2010
Philadelphia, PA
- Several years’ experience in working with cross disciplinary projects in an international setting
- Strong communication, organizational, and teamworking skills, ‘can-do’ attitude, and able to work in a structured and systematic manner across diverse culture
- Strong project leadership and stakeholder management skills
- Experience from engaging with trade organizations and authorities to influence legislation (e.g. AAFCO, FDA, AFIA)
- Experience with consultants and partners for addressing regulatory challenges and potential acquisitions
- Travel within North America as well as international travel (15%) with periodic trips to Copenhagen, Denmark required
- Provides strategic regulatory direction to teams on clinical trial application submission strategy, interaction and negotiation with regulatory agencies. Serves as a regulatory liaison on the project team throughout early development
Education
Oakwood University
1999 - 2004
Bachelor's Degree in Chemistry
Professional Skills
- Organized thought processes and prioritization skills; needs to possess strong program management skills
- Excellent communication skills in English - verbal, written and presentation skills
- Excellent prioritizing, organizational, and interpersonal skills Fluent in English speaking and reading ability
- Excellent documentation skills including record maintenance/tracking with a strong understanding of document traceability
- Strong multi-tasking, prioritizing and organization skills required
- Strong leadership skills with proven ability to influence, network and negotiate with key internal / external stakeholders
- Strong time management skills, have the ability to prioritize, multi-task and meet deadlines
How to write Regulatory Manager Resume
Regulatory Manager role is responsible for interpersonal, regulatory, english, leadership, technical, business, training, software, computer, communications.
To write great resume for regulatory manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Manager Resume
The section contact information is important in your regulatory 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 Manager Resume
The section work experience is an essential part of your regulatory 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 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 manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Manager resume experience can include:
- Provides advice to teams on several aspects of drug development, with major focus on early development, based on appropriate regulations and their interpretation
- Strong leadership skills and a proven track record in influencing to deliver commercial value, including
- Demonstrate strong management and leadership skills in implementing Quality Improvement program/organization strategies
- Developing strong relationships with, and effectively managing, third parties
- Strong organization and communication skills including oral and technical writing
- Strong interpersonal and client facing skills, drive and enthusiasm are a pre-requisite for this role
Education on a Regulatory Manager Resume
Make sure to make education a priority on your regulatory 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 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 Manager Resume
When listing skills on your regulatory 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 manager skills:
- Excellent documentation skills, with a solid process orientation and effective attention to detail
- Self-reliant, flexible, with good time management skills with ability to operate in an empowered environment with limited guidance
- At least three years pharmaceutical regulatory or compliance experience with demonstrated project management, interpersonal, and leadership skills
- Strong personal computer skills including databases, spreadsheets and word processing - utilize database software to run queries
- Excellent report writing and documentation skills including ability to modify style to meet the needs of the audience
- Critical thinking, active listening and strong interpersonal skills
List of Typical Experience For a Regulatory Manager Resume
1
Experience For Senior Regulatory Manager Resume
- Strategic thinking, creative problem solving, decision making skills required
- Demonstrated experience developing and delivering presentations to stakeholders and senior and executive management
- Proven ability to deal with complex regulatory issues and to develop effective strategies for managing them
- Fluent in English and preferably having skills in other languages
- Experience within Regulatory Affairs, preferably working within a fast moving consumer healthcare environment
- An in depth knowledge of the PAGB Code of Practice is essential, together with an excellent knowledge of other advertising Codes and labelling guidelines
- Experience with toxicological testing, hazard classification and labeling
- Has experience with documentation gathering
2
Experience For Quality / Regulatory Manager Resume
- Strong technical knowledge of regulatory capital calculations including
- Experience of working in an advisory capacity for a professional services firm would be an advantage
- Maintain good relationship, and establish networking with local and global teams
- Thorough Knowledge of, and Experience Working in an FDA/GMP Environment
- Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans
- Experience crafting positive relationships with global customers and functions
- Experience with agrochemical R&D including basic agronomy, greenhouse and research lab practices, and product development
- Preferably good understanding of agribusiness
- Experience in drafting legislation, regulation, policy, procedures, and public notices
3
Experience For Regulatory Manager, Flavors Group Resume
- Proven record of leadership and accomplishing goals successfully
- Develops and execute programs to ensure well-trained and experienced regulatory affairs personnel within region
- Experience with US submissions
- Develop a priority scheme for regulatory assessments affecting food packaging
- Tracking all activities, identifying areas of need and developing and implementing solutions
- Understanding, communicating and securing unmetered power possibilities for small cells
- Being aware of developments in Corbion Food regulatory playing field
- Handling of new appointments and dismissals of members of Supervisory and Management Board including fit & proper review
4
Experience For Global Regulatory Manager Resume
- Facilitating and leading community outreach programs to educate municipalities and neighborhoods of wireless facilities and small cells
- Writing and delivering results to prospective clients or team members
- Working knowledge of Health Canada Site and Establishment Licensing processes and API requirements an asset
- Working knowledge of Quality Management Systems – 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments
- Evaluating programmatic operations and processes
- Understanding agricultural practices, crop programs and their general technical background
5
Experience For Legal / Regulatory Manager Resume
- Cutting- edge knowledge of biocides regulatory area
- Working knowledge of MJ computer systems and databases.
- Working knowledge of basic lean tools
- Leading on regulatory policy developments for the GB capacity market
- Maintaining power of attorneys and procurations
- Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions
- Supervise the daily activities of the Rates Analysts, including coaching, counseling, development, and performance management
- Manages non-conforming material’s review board (MRB) system including WIP rejects and incoming materials
6
Experience For Safety Compliance & Regulatory Manager Resume
- Track record in developing a strategic agenda, delivering through others and working with virtual teams
- Lead the development of regulatory policies and initiatives that support business strategies, including the development and filing of rate case applications
- Reviews device labeling and advertising materials for compliance with applicable regulations
- Lead Substance Import (volume) Tracking & Reporting, where required
- Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders
- Coordinate the collecting date for expertise lobby taking to account the International regulation, regulatory newsletter
- Broader understanding of RB/MJ Global Business Operations, and regulatory and registration requirements affecting our products
7
Experience For Real Estate Regulatory Manager Resume
- 3) Tracking of well permit status and reporting periodically on progress to management team members within the Oklahoma City Division
- Is responsible for implementing regulatory strategy and managing operational activities for assigned regions
- Develop and facilitate Regulatory training to key stakeholders to ensure that they are up to speed with current and evolving legislation
- Familiar with working in an rapidly changing and dynamic environment
- Have deep understanding or the ability to grow this understanding of regulations that govern product category
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines
- An ability to present complex issues both in writing and in person, comprehensively, concisely, and appropriately targeted, depending on the audience
- An ability to provide innovative solutions to complex issues where appropriate rather than relying on existing solutions and procedures
- Familiar working within a regulated environment, deploying all the know-how and sensitivities that are necessary to work successfully in such an arena
8
Experience For Communication & Regulatory Manager Resume
- Oversee and evaluate new ingredients for compliance with regulations and to achieve sourcing certifications, such as Organic or Non-GMO
- Continually monitor adjustment tariffs, associated balancing accounts and prepare summary reports as necessary
- As part of Regulatory team, review and approve all consumer and customer communications (i.e. advertising, promotions, and digital content)
- Guides and directs the quality manager in his/her initiatives and ensures focus on value-adding, sustainable support
- Expert in Regulatory Affairs. Relevant practicing food law/regulatory affairs either in FMCG or law firm
9
Experience For Air Permit / Regulatory Manager Resume
- Represent CFMP in regulatory related working groups, project meetings, etc.
- Central Bank of Ireland prudential reporting
- Lead the Company’s Recall Program Including Lot Traceability and Mock Recalls
- Provide Insight into the risks of forthcoming regulatory issues for incorporation into relevant strategies and the 5-year plan
- Develop, agree and deploy external negotiating positions on key issues
- Oversee and manage the submission of accurate and timely regulatory reporting and information requests to Ofgem
- Comply with Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards
- Maintain professional working relationships with all employees, regulators, commission staff, business associates, consultants and customer
- RA monitoring - to check the Regulatory compliance with current regulations
10
Experience For Global Regulatory Manager, Immuno Resume
- Deepen understanding of US FDA infant formula regulations
- 2) Supervision, coordination, and training of regulatory staff
- 5) verification of compliance with State, Federal and local regulatory reporting requirements for all phases of operations within the Oklahoma City Division
- Maintain communication with staff to ensure meeting of goals and timelines
- Provides reports to leadership and makes recommendations for improving efficiencies
- Provides input into global regulatory strategy and, including identification of gaps or risks in global strategic plan for assigned regions
List of Typical Skills For a Regulatory Manager Resume
1
Skills For Senior Regulatory Manager Resume
- Good communication skills, verbal and in writing
- Proven project management skills involving tight timescales
- Experience of managing external resources effectively, e.g. economists
- Have good verbal, negotiation, influencing, analytical and written communication skills
- Good networking and communication skills across international dimensions
- Good analytical skills, including the ability to synthesise legal, economic, market, strategic and technical factors in the context of sectoral regulation
2
Skills For Quality / Regulatory Manager Resume
- Strong computer skills including Word, Excel, Outlook,
- First rate interpersonal skills and a proven ability to influence all levels
- Strong analytical skills with the ability to translate complex topics into simple, easily understood concepts
- Excellent communications skills in English and French both spoken
- Strong oral, written, and interpersonal communication skills required
- Established capability in finding solutions using great problem solving skills
- Handle multiple projects simultaneously, while exercising good judgment in prioritizing tasks required
3
Skills For Regulatory Manager, Flavors Group Resume
- Prioritization of clinical trials based on feasibility assessment and cancer center focus and adjusts short-term staffing priorities accordingly
- Demonstrated ability to lead, consult and make recommendations using effective oral and written communications
- Demonstrated ability and experience in liaising with legal counsel, regulatory bodies and agencies to gain required guidance/direction
- Good report writing experience
- Strong experience in Regulatory Affairs, preferably involving pesticides
4
Skills For Global Regulatory Manager Resume
- Demonstrates the ability to provide direction, the appropriate structure and effective resourcing to enable the team to perform at their best
- Demonstrated understanding/experience in key functional areas: New Product Development, Regulatory Affairs, Drug Safety, Medical Affairs, Clinical Affairs
- High Negotiation skills, project management, business writing, presentations
- Strong knowledge of liquid and packaging processes or scientific experience in alcoholic beverages, and the regulatory touch points that impact us
- Read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints
- Great interpersonal skills are essential
5
Skills For Legal / Regulatory Manager Resume
- Background in quantitative analysis, method validation, process validation, and project management are required
- Effectively interact with representatives from regulatory agencies in accordance with corporate guidelines
- Effectively manage multiple technical assignments and projects
- Understanding of Industry Standards for Equipment Operation, Maintenance and Validation
- Experience working on an external facing projects requiring public speaking and contract negotiations
- Experience working on an external facing project requiring public speaking and contract negotiations
- Experience working in a logistics or manufacturing environment
6
Skills For Safety Compliance & Regulatory Manager Resume
- Experience in a Safety / Regulatory role in a logistics or manufacturing environment, including internal and external audits
- Capable of good judgement in self-managing and escalating issues
- Four year’s people management experience. Track record of building and leading high performance teams
- Experience in applying regulations to food labeling required
- Demonstrated proficiency at leading complex multi-faceted projects and managing cross functional teams
- Experience in preparing and submitting regulatory dossiers
- Previous Experience Working In and Implementing Electronic Quality and Document Management Systems and Practices
7
Skills For Real Estate Regulatory Manager Resume
- Business and customer oriented - ability to prioritize and be proactive in meeting internal and external customer needs
- Demonstrated ability to developing and maintain project schedules
- Good knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry
- Assists regulatory staff with scheduling of site selection visits with sponsors and sponsor communication prior to scientific review
- Or more of experience and knowledge in a fragrance and/or flavor industry, or chemical manufacturing or consumer product company
8
Skills For Communication & Regulatory Manager Resume
- Some regulatory/compliance experience and knowledge of clearing/exchange operations is desirable
- Experience engaging on technical topics with modellers
- Good understanding of regulatory science and ability to communicate on science matters
- Five (5) years experience in a healthcare setting in administration or a clinical area
- Three (3) years of training and experience in management, program development, project coordination and/or equivalent
- Strong understanding of Joint Commission is essential
- At least eight years of CP regulatory experience, ideally having worked a couple of different levels of regulatory (country, territory, region, global)
9
Skills For Air Permit / Regulatory Manager Resume
- Advertisement and Promotional Material experience with an understanding of compliance with US regulations and guidelines related to commercial communications
- Experience in working with an international company across many cultures and time zones
- Good understanding of regulatory processes in the EU, with exposure to biopesticide and /or fertiliser/biostimulant regulation
- Experience managing subordinates
- Experience in a regulatory compliance role with leading CPG food manufacturers
10
Skills For Global Regulatory Manager, Immuno Resume
- Data collection, research methodologies for compliance testing (Process Controls Effectiveness)
- Significant experience in regulatory affairs, ideally including regulatory affairs for Biocides and/or Medical Devices
- Excellent working knowledge of the EU regulatory framework for biocides and/or medical devices
- Good understanding of chemistry, efficacy, toxicology, ecotoxicology, environmental fate studies or risk assessment methodologies
- Experience in working with RB/MJ databases
- Experience in a policymaking role
- Experience performing legal research
List of Typical Responsibilities For a Regulatory Manager Resume
1
Responsibilities For Senior Regulatory Manager Resume
- Proactively identify inconsistencies between client account activity as compared to internal investment policy guidelines, the client’s stated investment objectives, risk tolerances and portfolio goals, and work with PWM Teams to address
- Previous Wireless Real Estate Experience with demonstrated skills in lease negotiations
- Fluent English in verbal and written; good computer skill, good presentation skill
- Strong personal relationship and communication skills are necessary
- Fluent English. Strong communication, people and organizational skills
- Work Experience: good communications with authorities (RPN, Veterinary services, Rosaccreditation), the At least 3 years experience in RA
- Strong customer focus and good team player who has the ability to work with a large group of people
- Effectively promote expertise of self and others
2
Responsibilities For Quality / Regulatory Manager Resume
- Experience Influencing Colleagues and Management in A Cross-Functional Environment
- Experience Operating in an Environment with Strict Timelines
- Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives
- Quality and regulatory experience working in an ISO 9001/14001 environment
- EMC qualification, 3+ years’ managerial experience, automotive industry background required
- Experience with OSHA safety/compliance, HazMat HazMat (DOT, IMDG, IATA) regulations as it relates to the Chemicals industry
3
Responsibilities For Regulatory Manager, Flavors Group Resume
- Experience related to Independent System Operators (ISO) or in a government relations role is desirable
- Coordinate global project prioritization
- Prioritises work to remain focused on objectives in rapidly changing circumstances
- Experience in a legal department at a law firm or banking legal department
- Previous supervisory experience including creation of development plans and conducting performance reviews
- Experience with Agilent LSAG’s products
- Experience in cross-functional project or program management
- Manage multiple tasks and priorities and escalate appropriately
- Experience of all phases of the drug development process in regulatory affairs,
4
Responsibilities For Global Regulatory Manager Resume
- Previous experience with electronic regulatory submissions and document management systems
- Relevant experience directly in the cosmetic area preferably in the same regions to be covered in this job
- EU regulatory experience of at least 5-10 years
- Some experience in regulatory compliance matters would be desirable
- Demonstrated ability to lead, grow in a Leadership position, and enable Team members to grow as well
- Business development experience (desired)
- Scientific experience
5
Responsibilities For Legal / Regulatory Manager Resume
- RA experience in medical device company, especially Shonin or Ninsho submission
- Experience in regulatory and compliance related activities
- Experience in Regulatory Affairs
- Support to keep and defend License to Operate (LtO) of Syngenta products
- Holding Site Acquisition vendors accountable for delivering quality leases/amendments, zoning, building permit and ultimately NTP’s and overall results
- Evaluating and onboarding of employees, prospective vendors and contractors
- Working knowledge of SItetracker and FUZE project management tools
- Support corporate training program, including development of training materials
6
Responsibilities For Safety Compliance & Regulatory Manager Resume
- Ensure traders follow the firm’s policies with regards to markups/markdowns by monitoring daily trading activity
- Support the innovation pipeline by providing regulatory screening of development candidates
- Comprehensive knowledge of regulatory labeling requirements for FDA and USDA and nutrition labeling
- Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management
- Provision of information regarding relevant legislation, guidance and company policy regarding our products
- Coordinate with Corporate Compliance in the updating of firm’s WSPs as needed
- Coordinate and provide proactive collaboration, advise and decision making in the project/product development milestones
7
Responsibilities For Real Estate Regulatory Manager Resume
- Drive continuous improvement thinking and action across the healthcare division in NA
- Coordinate recall and reporting to FDA and Canada Health
- Provide expert advice/guidance to the PC Business Team assuring compliance of new product initiatives with regulatory requirements
- Solicit bids, negotiate and awarding contracts associated with real estate services - from inception through completion
- Maintain a positive work environment, as measured by the results of Employee Opinion Surveys, while meeting targeted Team and personal objectives
- Collaborate with flavor suppliers’ regulatory departments regarding compliance activities
- Monitor globally for emerging trends, policies, regulations and guidance in animal feed & health; analyze and communicate regulatory intelligence
- Assist with the development of Group policies/ guidelines and responses to new and changing legislation
8
Responsibilities For Communication & Regulatory Manager Resume
- Work with external consultants and agencies regarding the requirements of international legislation
- Flexible to travel as and when required to support implementation and monitoring of regulatory best practice
- Provides technical guidance and training to staff
- Prepares submissions for device design changes and /or manufacturing changes
- Reviews product and manufacturing changes for compliance with applicable regulations (Change Control)
- Identify and define SDS and product labelling requirements, based on country needs within the region
- Lead hazard communication requirements tracking and communication
- Manage the strategy to maximize the claim approval opportunities following CSS through scientific innovation framework for product label and advertisement
9
Responsibilities For Air Permit / Regulatory Manager Resume
- Manage all projects going through the business from a regulatory and nutrition point of view and ensure accountability for this work
- Ensure through dynamic resourcing that appropriate support (Subject Matter Experts) is given to the Innovation projects & team
- Openness to challenge the accepted ways of working, to implement new ones and to try new approaches
- Travel Required-Approximately 10% depending on role and business needs
- Ability and confidence to provide advice to a wide range of colleagues within the business including, on occasions, at a senior level
10
Responsibilities For Global Regulatory Manager, Immuno Resume
- Capable of leading functional or cross-functional teams or projects
- Provides regulatory guidance and expertise for development and review of labeling materials for U.S. marketed products
- Support headcount and budget planning accuracy
- Responsible for ensuring that medicinal, medical device and cosmetic products can be legally sold and supported in compliance with regulations
- Provide advice, recommendations and support for product claims, copy and labelling
- Employ quality techniques to aide site management in problem solving
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