Associate Director, Regulatory Science

Title: Associate Director, Regulatory Science Location: Remote (United States)

The Opportunity:

The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

• Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior personnel concerning risks.

• Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.

• Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.

• Able to proactively identify risks and devise mitigation strategies.

• Function as a Regulatory Science subject matter expert member of cross-functional teams, including study teams and submission teams.

• Perform regulatory research to inform business strategy. Assess and communicate risks.

• Assure that there are no significant interruptions to the business due to regulatory compliance issues.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 9+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.

• Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.

• Experienced in representing Regulatory Science on cross functional teams and presenting to senior management. Excellent communicator.

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

• Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.

Preferred Skills:

• Direct experience with oncology drug development highly preferred.

• Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.

• Direct experience with FDA expedited programs highly preferred.

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