Job ID: 7663
Job Title: Executive Director Regulatory Affairs
Location: New Jersey, NJ
My client is a commercial-stage pharmaceutical company with a strong portfolio of marketed products and a diverse pipeline of development programs spanning multiple therapeutic areas. The organization fosters a collaborative, patient-centered culture and is committed to advancing science through strategic partnerships and continued investment in innovative research.
They are seeking an Executive Director of Regulatory Affairs to provide strategic leadership and direction for global regulatory activities across both development-stage programs and post-approval initiatives. This individual will be responsible for developing and executing regulatory strategies that align with business objectives and ensure successful regulatory outcomes.
Position Overview: The Executive Director of Regulatory Affairs will lead the development and submission of investigational applications, NDAs/BLAs, MAAs, and related supplements. This role provides strategic regulatory direction, guiding project teams in interactions with health authorities to expedite approvals and address inquiries.
Responsibilities:
- Provide global regulatory leadership in support of the global development, registration, and lifecycle management of products under responsibility.
- Ensure the efficient, timely, and compliant execution of regulatory strategies and programs.
- Directs and manages a team of regulatory professionals responsible for the development of global regulatory strategic plans for new product development, as well as life cycle management of existing products.
- May serve as the lead regulatory representative on the project team throughout the product lifecycle.
- Provide senior staff with advice and guidance on regulatory issues, especially those related to the US.
- Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities and the CDE.
- Actively participates in Health Authority GCP inspections (e.g., FDA, EMA, PMDA), including responding to observations and the development of corrective actions.
- Stay informed about changes in the regulatory environment and implement necessary adjustments.
- Provide expert opinion, advice, and strategic direction on emerging policy & intelligence matters.
- Ensure continued engagement, development, and performance management of staff.
- Determining timelines and budgets for program activities and report accordingly.
- Lead and participate in global regulatory initiatives and committees.
Qualifications:
- Bachelor’s degree and at least 12 years of industry experience with a minimum of 10 years of direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.
- Education area of study in a scientific discipline with a Master’s or other advanced degree preferred.
- The position involves line management responsibility for personnel in the US and UK, with both direct and indirect reports. Demonstrated success in leading and managing teams is required.
- Experience in the successful prosecution of NDA/BLA, MAA, and supplementary applications is essential.
- Demonstrated track record of interfacing effectively with FDA, EMA, and other global regulatory agencies.
- Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).
- Strong strategic skills, including the ability to make complex decisions and willingness to defend difficult positions.
- Excellent operational skills, including planning, organizing, and the ability to motivate and lead others.
- Excellent verbal and written communication skills and comfortable presenting to all levels of an organization, including its Senior Management.
- Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure and acting with integrity and credibility to build trust.
- Ability to effectively work with a variety of personnel across a matrix organization and work collaboratively with cross-functional teams.
- Sense of urgency and perseverance to achieve results.