Senior Manager, Regulatory Affairs Job Description
Senior manager, regulatory affairs
provides strategic guidance to Core Labeling Teams (CLTs) regarding new and revised labeling regulations, competitor labeling, and labeling trends.
Senior Manager, Regulatory Affairs Duties & Responsibilities
To write an effective senior manager, regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included senior manager, regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Identify and define key regulatory CMC issues related to the pre-clinical and clinical development and manufacturing of products
Lead liaison support for CMC regulatory affairs function at the company as assigned
Review CMC and clinical data/information related to regulatory submissions
Work closely with manufacturing colleagues to resolve complex CMC issues as assigned
Support the company's organization by expanding the company knowledge base of regulations and guidelines governing the research, development, and marketing of drugs and biologics
Provide US regulatory intelligence, including interpretations of applicable or newly issued regulations and guidelines
Keep project team abreast of regulatory decisions, issues, potential problems and new regulations
Ensure that internal and external commercial marketing materials are reviewed in a timely manner, and that content and claims are consistent with approved product labeling
Ensure that materials and claims are consistent with approved product labeling, as appropriate, and that internal and external communications are adequately supported
Interpret country regulations and provide regulatory insight plus guidance to support organizational objectives, to reduce risk and to drive regulatory compliance
Senior Manager, Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manager, Regulatory Affairs
List any licenses or certifications required by the position: RAC, MDD, ISO, MDR, BS, BA, QMS, UK, CFR, FDA
Education for Senior Manager, Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the senior manager, regulatory affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Pharmacy, Chemistry, Medical, Life Sciences, Technical, Biology, Education, Life Science
Skills for Senior Manager, Regulatory Affairs
Desired skills for senior manager, regulatory affairs include:
Regulations
CMC
Labeling
Clinical development
Commercialization
Domestic and international laws
Labeling negotiations
Marketing authorization
Meeting facilitation
Operations
Desired experience for senior manager, regulatory affairs includes:
Support the preparation and implementation of regulatory strategies, including clinical strategy, for new drug/biologics development projects in the US and North America, and in other regions
Provide US specific regulatory input for development projects destined for the US market
Represent the company RA function on the Global Project and Regulatory Teams, as assigned
Review Quality and manufacturing change control documentation as assigned
Collaborate with and manage Regulatory consultants and other vendors when required
Support the initiative of electronic submissions
Senior Manager, Regulatory Affairs Examples
1
Senior Manager, Regulatory Affairs Job Description
Job Description Example
Our company is looking to fill the role of senior manager, regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior manager, regulatory affairs
- Maintain a comprehensive understanding of relevant advertising/promotional regulations and guidances including those related to labeling, product promotion
- Participate according to business need on the marketing application development of new products’ labeling as related to promotional labeling opportunities and restrictions
- Develop and implement strategies to facilitate the progress of Phase I through Phase III clinical development programs
- Review advertising, promotional and other related materials for assigned products to ensure compliance with applicable U.S. Food and Drug Administration (FDA) laws, regulations, and guidance
- Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products
- Serve as functional CMC representative on assigned New Product Development teams and related technical task forces In-Line projects such as site transfers
- Represents regulatory CMC and provides US regulatory filing strategy recommendations to interdisciplinary project teams
- Collaborate with commercial operation/marketing staff to mitigate regulatory risk on promotional labeling /communications
- Assess impact of and implement appropriate actions to new regulations, guidances, or enforcements
- Provide support and expert input on critical scientific and regulatory issues
Qualifications for senior manager, regulatory affairs
- Proactively identify, develop, and execute initiatives, programs, partnerships, coalitions and stakeholder networks, with the objective of minimizing regulatory and scientific barriers and/or leverage regulatory and scientific opportunities to support our renew growth strategy
- Provide leadership, strategic and tactical direction execution and oversight of the Regulatory Advertising & Promotion review team, performing global LifeScan, Animas and Calibra Copy Review activities
- Partner with cross-functional reviewers
- Actively collaborate with senior marketing management to provide strategic direction to develop new campaign ideas
- Demonstrate a balanced approach to risk tolerance
- Provide management oversight, direction and support to team members
2
Senior Manager, Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior manager, regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior manager, regulatory affairs
- Within the framework of Canadian and US Federal regulatory acts, represent CN in discussions and working groups with regulators and railway industry to develop and advance new regulations or carry out modifications to existing regulations which best ensure that CN’s interests are protected
- Defines product labeling data requirements
- Responsible for staffing, budgetary management, review process and personnel development and management
- Create and execute the strategies for obtaining new product registrations and supporting the lifecycle management of product portfolio
- Provides regulatory leadership to develop and sustain productive relationships with in-country business partners
- Monitor the external regulatory environmental changes and engage in shaping activities through industry association
- Maintain a positive relationship with health authorities through frequent and transparent dialogue
- Identify and communicate regulatory requirements necessary to perform clinical studies in the assigned markets
- Lead RA team and strengthen talent development for RA staff
- Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, GPT as requested
Qualifications for senior manager, regulatory affairs
- Align team members’ activities to business goals
- A minimum of a Bachelor’s degree is required, preferably in a Life Sciences related discipline
- Strong influencing skills to drive accountability of the business to meet its regulatory obligations
- Enhanced PC knowledge and skill sets utilizing Microsoft Office (Word, Excel, PowerPoint)
- MS in Regulatory Affairs
- Experience in business or product management in in vitro diagnostic regulated industry
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Senior Manager, Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of senior manager, regulatory affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior manager, regulatory affairs
- Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues
- Lead cross-functional team to develop complex regulatory submissions
- Manage internal personnel and activities of external contractors
- Develop individual talent and coach others to produce results
- Provide regulatory expertise, strategy, and guidance with respect to creation and execution of advertising, promotional and other related materials
- Serve as primary contact with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products
- Review and approve Form FDA-2253 submissions to OPDP
- Represent Merial involving key interactions with multiple trade associations (at various levels) to help incorporate Merial objectives
Qualifications for senior manager, regulatory affairs
- 4-7 years previous pharmaceutical drug development experience
- In-depth understanding of CTD modules
- Effective project manager, developing leader
- Ability to lead complex regulatory submissions
- Direct experience in oncology
- BA/BS degree in the life sciences
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Senior Manager, Regulatory Affairs Job Description
Job Description Example
Our growing company is looking for a senior manager, regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior manager, regulatory affairs
- Together with professionals from other departments and in other countries, translating regulations and standards into product requirements
- Reviewing and approving engineering changes, advertising, promotional items and labeling for regulatory compliance
- Represent Merial Regulatory Affairs in Due Diligence visits involving corporate acquisition or merger initiatives (companies and/or products)
- Have accountability for ensuring that Senior Management is aware of any major issues with the project, including any changes to risks, so that appropriate message is communicated on a one single regulatory voice to any key project governance milestone committee
- Interact directly with FDA for each project and ensure that communications from FDA are properly communicated to the business and up through Senior Management
- Coordinate timely dispatch of CTD dossiers components to the FDA, coordinate the responses to FDA questions
- Contribute to regulatory affairs quality and continuous improvement initiatives
- Have responsibility for keeping abreast of regulatory guidance and technical/scientific developments relevant to project
- Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences
- Liaise proactively with internal cross-functional teams external partners supporting development activities
Qualifications for senior manager, regulatory affairs
- Generally strong in working well with others and within global teams
- Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
- BA/BS Degree, preferably in a health/life sciences or related field
- Minimum of three years of experience (Sr
- Commercial launch and advisory comment process experience preferred
- Must have previous experience in leading Major Health Authority interactions
5
Senior Manager, Regulatory Affairs Job Description
Job Description Example
Our company is hiring for a senior manager, regulatory affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior manager, regulatory affairs
- Establish and support a work environment of continuous improvement that supports MAQUET’s Quality Policy, Quality System and the appropriate regulations for the areas this position supports
- Develop and strengthen relationships with Chinese Regulatory agencies –CFDA, CDE, CFDI, NIFDC, Ch.P
- Responsible for performance (quality, profitability, utilisation) of direct reports, ensuring consistent regulatory support, in accordance with Global Regulatory Affairs business plans
- Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies
- Contributes to the compilation of high quality documentation for submissions in the region ensuring content and format requirements are met
- Monitor current and proposed regulatory requirements to provide applicable regulatory advice to project teams to ensure HA compliance while meeting business objectives
- Mentor Regional Managers and /or Regulatory Specialists
- Work with CN Law department to develop CN strategy for negotiated cost sharing negotiations involving grade separations, road and utility crossings and fencing
- Preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Pre-Submission, 510(k), de Novo, PMA supplement, PMA annual report)
- Define, develop and implement Area & Affiliate regulatory strategies & deliverables for compounds at all stages of development
Qualifications for senior manager, regulatory affairs
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, Global, European, International, Marketing Company or experience at a health authority
- A minimum of 6 years of directly related regulatory international bio/pharmaceutical experience
- Demonstrated leadership, problem-solving ability, flexibility and teamwork
- Experience managing relationships with CROs and/or contractors
- Proven ability to provide strategic regulatory guidance to drug development, registration and post-market support team
- Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles in development