Senior Manager, Clinical Regulatory Affairs
New
J
JobgetherBiotechnology
Based in the United StatesFull-TimeManager
Salary159,800 - 197,400 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 5+ years of relevant Regulatory Affairs experience for Senior Manager level.
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or related discipline; advanced degree preferred.
- 5+ years of relevant Regulatory Affairs experience for Senior Manager level.
- Hands-on experience with FDA submissions and interactions (INDs, amendments, annual/safety reports, briefing packages).
- Experience supporting EU and global clinical trial applications (CTAs) and engagement with EMA or national authorities.
- Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements, and GCP.
- Experience in biotechnology, pharmaceutical, cell therapy, or gene therapy environments preferred.
- Strong project management, organization, and prioritization skills.
- Excellent written and verbal communication skills for technical documents and summaries.
- Ability to travel as needed.
- Ability to work evenings, holidays, or weekends when required.
Responsibilities
- Develop and implement global clinical regulatory strategies for early- and mid-stage programs.
- Prepare, review, and support regulatory submissions including INDs, CTAs, protocol amendments, and briefing packages.
- Manage planning and preparation for meetings with health authorities like the FDA and EMA.
- Provide regulatory input on clinical study designs, protocols, and investigator brochures.
- Monitor regulatory requirements and competitive intelligence in oncology and immunotherapy.
- Identify regulatory risks and implement mitigation strategies for development programs.
- Represent Regulatory Affairs on cross-functional project teams.
View Full Description & ApplyYou'll be redirected to the employer's site
