Associate Director, Regulatory Affairs
J
JobgetherOncology biologics
Based in United StatesFull-TimeDirector
Salary185,000 - 210,000 USD per year
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Job Details
- Experience
- Minimum of 5 years of regulatory affairs experience with a doctorate such as MD, PhD, PharmD, or equivalent. Alternatively, 8 years of regulatory affairs experience with a master’s degree or 10 years with a bachelor’s degree.
- Required Skills
- Project Management
Requirements
- Hold a bachelor’s degree in life sciences.
- Have at least 5 years of regulatory affairs experience with a doctorate such as MD, PhD, PharmD, or equivalent; alternatively, 8 years with a master’s degree or 10 years with a bachelor’s degree.
- Demonstrate experience supporting late-stage oncology drug development programs.
- Have experience developing and negotiating clinical-regulatory strategies with health authorities, including ex-U.S. agencies.
- Be able to develop, write, edit, or collaborate on clinical-regulatory documents.
- Have experience with briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.
- Be able to manage multiple regulatory projects and submissions simultaneously.
- Demonstrate strong organizational, planning, and project management skills.
- Have strong judgment, analytical thinking, troubleshooting, and problem-solving abilities.
- Experience with biologics, cell and gene therapies, or advanced therapy medicinal products is preferred.
- An advanced degree such as MS, MPH, PharmD, or PhD is preferred.
Responsibilities
- Develop and execute U.S. and global regulatory strategies for assigned development programs.
- Collaborate with functional leaders to establish clinical and regulatory development pathways.
- Plan, manage, and prepare Clinical Trial Applications, Marketing Applications, and regulatory amendments.
- Lead cross-functional teams in developing strategic briefing packages.
- Coordinate preparation for health authority meetings and other regulatory interactions.
- Monitor global regulations, guidelines, and health authority expectations relevant to biologics and advanced therapies.
- Incorporate changing regulatory requirements into program strategy and decision-making.
- Manage multiple projects and submissions while adapting priorities to new data and program changes.
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