Associate Director / Director Regulatory Affairs
Hybrid - 3 days onsite
6 month initial contract (likely exetnsion and convert to FTE)
Responsibilities:
- Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior 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 Affairs 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 7 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 Affairs 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 Skillset:
- 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.