Associate Director, Regulatory Science

Location: Remote (United States)

Department: Regulatory Affairs

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:

• Bachelors 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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