About the Company
We are seeking an experienced Global Regulatory Lead (GRL) to provide maternity leave cover for a key regulatory leadership position. This individual will be responsible for leading global regulatory strategy and execution across oncology programs, working closely with cross-functional teams and regulatory authorities to support successful development and registration activities.
About the Role
The ideal candidate will have substantial pharmaceutical or biotechnology industry experience, including a proven track record of leading regulatory filings and submissions, particularly with the FDA's Centre for Drug Evaluation and Research (CDER).
Responsibilities
- Act as the Global Regulatory Lead for assigned oncology programs.
- Develop and execute global regulatory strategies to support development and registration objectives.
- Lead regulatory planning and provide strategic guidance to cross-functional teams.
- Serve as the primary regulatory representative within project teams and governance forums.
- Lead the preparation, review, and submission of regulatory filings to FDA/CDER and other global health authorities as required.
- Provide regulatory leadership for major submissions, including INDs, NDAs, BLAs, and lifecycle management activities.
- Coordinate regulatory responses to agency questions and information requests.
- Lead regulatory agency meeting preparations and support health authority interactions.
- Assess regulatory risks and develop mitigation strategies to ensure successful program progression.
- Ensure regulatory activities are delivered on time and in compliance with applicable regulations and company standards.
Qualifications
- Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
- Significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Strong oncology regulatory experience is essential.
- Demonstrated experience as a Global Regulatory Lead or in a similar regulatory leadership role.
- Proven experience leading regulatory filings and submissions to FDA/CDER.
- Strong knowledge of U.S. regulatory requirements and drug development processes.
- Experience leading cross-functional teams and influencing senior stakeholders.
- Excellent communication, project management, and stakeholder engagement skills.
Required Skills
- Significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Strong oncology regulatory experience is essential.
- Demonstrated experience as a Global Regulatory Lead or in a similar regulatory leadership role.
- Proven experience leading regulatory filings and submissions to FDA/CDER.
- Strong knowledge of U.S. regulatory requirements and drug development processes.
- Experience leading cross-functional teams and influencing senior stakeholders.
- Excellent communication, project management, and stakeholder engagement skills.
Preferred Skills
- Advanced degree preferred.
Pay range and compensation package
Contract Length: Initial 6-month contract (maternity cover)
Equal Opportunity Statement
Candidates must be based in the United States. Remote working is acceptable. Ability and willingness to travel periodically to New Jersey for key meetings and business-critical activities. Availability to start in July/August 2026 is preferred.