Senior Director of Regulatory Affairs

Senior Director of Regulatory Affairs - Oncology

My client is looking for a Senior Director of Regulatory Affairs (Senior & Executive Director level) to join their team for their growing oncology portfolio. They are revolutionizing the oncology space with their lead indication approaching phase III.

You will lead their regulatory initiatives and ensure compliance with global regulations. The ideal candidate will have extensive regulatory strategy experience in NDA, and a deep understanding of the regulatory landscape in the oncology space.

Key Responsibilities:

• Develop and implement regulatory strategies to ensure successful registration and approval of oncology drug and CDx products.
• Lead regulatory submissions, including INDs, NDAs, CTA's, and ensure timely responses to regulatory authorities.
• Oversee the preparation and review of regulatory documents, including clinical trial applications, marketing authorization applications, and labeling.
• Collaborate with cross-functional teams, including R&D, clinical, quality, and manufacturing, to ensure regulatory requirements are met throughout the product lifecycle.
• Provide regulatory guidance on clinical trial design, including endpoint selection, patient population, and statistical analysis plans.
• Ensure compliance with global regulatory requirements, including FDA, EMA, and other international health authorities.
• Manage interactions with regulatory agencies, including leading meetings and negotiations to facilitate product approvals.
• Monitor and assess the impact of regulatory changes and trends on company projects and strategies.
• Train and mentor the regulatory affairs team, fostering a culture of compliance and continuous improvement.

Qualifications:

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field, advanced degree preferred (Ph.D., Pharm.D., M.D., or equivalent preferred).
• Minimum of 10 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with a focus on oncology (small molecule) and/or CDx.
• Proven track record of successful regulatory submissions and approvals in major markets (US, EU, etc.).
• In-depth experience developing global regulatory strategies.
• Excellent leadership, communication, and negotiation skills.
• Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.

Please send a copy of your resume to caroline.schlueter@lifescience-people.com