Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions.
My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation research. As Senior Director of Regulatory Affairs, you'll drive regulatory strategy, filings, and engagements. Your focus will be on guiding product development through nonclinical and clinical regulatory processes, ensuring compliance and optimizing success.
Responsibilities:
Develop global regulatory plans and manage submissions for oncology products.
Ensure program efficiency while meeting regulatory requirements.
Coordinate meetings with regulatory agencies and stay updated on global changes.
Drive process improvements locally and globally.
Preferred Skills and Experience:
PhD, MD, or PharmD in a scientific discipline.
10+ years in Regulatory Affairs within biotech or pharma.
Strong regulatory strategy and submission experience.
Familiarity with global regulatory frameworks and Electronic Common Technical Document format.
Ability to travel for agency meetings.
Scientific background in oncology, endocrinology, or neurology preferred.
Previous management experience.
If this is something you would be interested in learning more about, please do not hesitate to reach out.