This clinical-stage biopharmaceutical company is advancing innovative therapies for cardiovascular disease and other lipid-related conditions. They are seeking a SVP, Head of Global Regulatory Affairs to oversee all regulatory strategies and submissions, and lead a growing team. Reporting into the Chief Medical Officer, this individual will lead the strategic direction and operational aspects for Regulatory Affairs including CMC regulatory, preclinical and clinical regulatory, and post-approval regulatory globally. This company offers a science-based and patient-focused culture, with the ability to work remotely. With multiple programs in Phase 3 trials and a pending drug approval, now an exciting time to join this growing organization!
Responsibilities:
- Develop US and global regulatory strategies aligned with business objectives for a portfolio of cardiovascular and metabolic therapeutics.
- 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, provide expert advice to development teams, and operationalize key regulatory activities.
- Serve as the primary liaison with FDA and other regulatory authorities for day-to-day interactions.
- Coordinate and prepare responses to requests for information from regulatory authorities.
- Oversee preparation of health authority meeting requests and briefing documents; coordinate and prepare teams for health authority meetings.
- 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.
- Identify areas of growth and opportunity for current talent, as well as forecast team capability needs with the evolving pipeline.
- 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.
- Represent the regulatory function on the cross-functional development team(s).
- 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.
- Establish, update, and implement regulatory policies, standards, and procedures for the Company.
- Train, mentor, and develop members of the Regulatory team to ensure optimal results.
- This position may potentially have oversight of the Quality Assurance function (TBD).
Qualifications:
- Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
- A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry with 10 years in a senior leadership role.
- Regulatory experience with cardiovascular and/or metabolic programs desired, but not required.
- A track record of successful interactions and negotiations with FDA, EMA, and other regulatory agencies.
- Experience supporting late phase development, including development and filing of marketing applications (NDA/BLA/MAA).
- Track record of successful drug approvals in the US and/or in Europe.
- 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.
- Strong European and ex-US/global regulatory experience required.
- 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.
- Ability to accurately project timelines and manage them across regulatory projects.
Leadership and Interpersonal skills:
- Experience leading a team of regulatory professionals and external partners, with a preference for leading a team through stages of company expansion.
- 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.
- Excellent listening, communication, and interpersonal skills.
- A track record of fostering team collaboration and consistently delivering high-quality work.
- Must be comfortable with ambiguity in a small biotech environment.
This is remote position with some travel required as determined to meet business requirements. NOTE: Our client strongly prefers candidates on the East Coast.
The budgeted salary range for this position is $375,000 to $425,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.