Job Description:
SVP, Head of Global Regulatory Affairs
Head of Global Regulatory Affairs, is a strategic leader supporting NewAmsterdam Pharma’s efforts to develop NAP’s regulatory strategy including all global regulatory submissions with the goal of obtaining approval for commercializing product(s) across geographic regions. The individual in this role will lead the strategic direction and operational aspects for Regulatory Affairs, responsible for all regulatory aspects related to CMC, preclinical, clinical development, and post-approval globally. This person will be responsible for preparing regulatory development strategies, advising management on regulatory risk, and leading interactions with regulatory agencies on behalf of the company.
Role reports to the Chief Medical Officer
Key Responsibilities:
- Develop US and global regulatory strategies aligned with business objectives.
- Provide guidance, direction, and leadership on those strategies to the development team and senior management.
- Make strategic contributions to clinical development plans.
- Lead the regulatory team to continue to provide expert advice to development teams, and operationalize key regulatory activities.
- Identify areas of growth and opportunity for current talent, as well as forecast team capability needs with the evolving pipeline.
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be the primary liaison with regulatory authorities for day-to-day interactions.
- Maintain up-to-date working knowledge of US, EU laws, regulations, and guidelines as well as familiarity with the global regulatory environment.
- Identify and collaborate with regulatory experts and consultants.
- Coordinate and prepare responses to requests for information from regulatory authorities
- Represent the regulatory function on the cross-functional development team(s).
- Establish, update, and implement regulatory policies, standards, and procedures for the Company.
- Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management, including labeling updates, supplements/variations, renewals, post-marketing commitments, and health authority interactions for commercialized or near-launch products.
- Partner with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access to ensure launch readiness, compliant product communications, global labeling strategy, and effective lifecycle planning.
- Ensure regulatory operations are compliant with FDA, EU, ICH, EMA, and industry standards.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions.
- Author, review and/or edit documents i.e., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports as necessary.
- For the EU, work with the selected EU Designated Person to ensure Good Distribution Practices of API.
- Remote position, travel required as determined to meet business requirements
Qualifications:
- An Advanced degree preferred.
- 15+ years of regulatory experience and a minimum of 10 years of experience in a senior leadership role.
- Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people.
- Experience leading a team of regulatory professionals and external partners, with a preference for leading a team through stages of company expansion.
- Excellent working knowledge of drug development process and understanding of regulatory environment across USA, EU, and other regions
- Demonstrated experience leading regulatory strategy for late-stage, launch, and commercial-stage products in the US and ex-US markets.
- Experience with post-approval regulatory activities, including labeling strategy, safety-related updates, CMC changes, post-approval commitments, renewals, and supplements/variations.
- Proven ability to advise executive and commercial leadership on regulatory risks affecting launch timing, market access, labeling, competitive positioning, promotional strategy, and lifecycle management.
- Ability to provide strong regulatory leadership on a cross-functional team
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development.
- Excellent listening, communication, and interpersonal skills, with a track record of fostering team collaboration and consistently delivering high-quality work.
- Ability to accurately project timelines and manage them across regulatory projects.
Salary and Benefits:
We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.