Associate Director, Regulatory Affairs
J
JobgetherBiotechnology
Based in the United StatesFull-TimeManager
Salary$170,000–$195,000, depending on experience, qualifications, and internal practices.
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Job Details
- Experience
- 7+ years of experience in the pharmaceutical or biotechnology industry, including at least 4 years in Regulatory Affairs.
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in a scientific discipline or equivalent professional experience; advanced degree (MS, PhD, or PharmD) preferred.
- 7+ years of experience in the pharmaceutical or biotechnology industry.
- Minimum 4 years of experience specifically in Regulatory Affairs.
- Demonstrated experience in oncology and across multiple stages of drug development.
- Proven experience preparing and supporting global regulatory submissions, particularly FDA NDA and BLA filings.
- Strong working knowledge of drug development processes and regulatory frameworks.
- Experience supporting interactions with the FDA and other health authorities.
- Excellent organizational and project management abilities to handle multiple priorities and complex workstreams.
- Strong interpersonal, communication, and leadership skills to influence cross-functional teams.
- Demonstrated proficiency with AI tools for professional work.
- Ability to travel up to 10%.
Responsibilities
- Contribute to the development and execution of global regulatory strategies for cross-functional teams.
- Support end-to-end regulatory planning and execution for submissions including INDs, NDAs, BLAs, and orphan drug applications.
- Serve as a regulatory liaison with the FDA and other global health authorities, preparing briefing materials and meeting documentation.
- Represent Regulatory Affairs on Project, Clinical, and Study teams to ensure alignment with development objectives.
- Manage regulatory consultants, CROs, and other external vendors to ensure high-quality, timely contributions.
- Monitor regulatory intelligence and integrate updates into actionable recommendations for the business.
- Develop and maintain regulatory SOPs and processes to ensure operational excellence and compliance.
- Participate in regulatory due diligence and provide insights for business development activities.
- Utilize AI tools to improve research, analysis, and operational productivity.
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