Director, Regulatory Affairs
New
H
HumacyteBiotechnology
United States; Headquarters or Remote, East Coast USFull-TimeDirector
Salary not disclosed
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Job Details
- Languages
- Effective written and verbal communication in English
- Experience
- At least five years of regulatory project lead experience required.
- Required Skills
- Cross-functional Team LeadershipMicrosoft ExcelPowerPoint
Requirements
- Hold a graduate degree in a life science; a Ph.D., M.D., or Pharm.D. is highly preferred.
- Have at least five years of regulatory project lead experience.
- Bring recent hands-on experience leading BLA submissions, preferably to FDA’s Center for Biologics Evaluation and Research (CBER).
- Have recent experience supporting biologics development.
- Demonstrate successful submission and FDA approval of a BLA or New Drug Application (NDA).
- Have experience serving as a point of contact for FDA and other health authorities and leading formal health authority meetings.
- Know FDA content and technical requirements for BLA submissions.
- Demonstrate experience developing and implementing regulatory strategies for U.S. Investigational New Drug applications (INDs), BLAs, and/or NDAs.
- Be able to lead cross-functional teams, manage submission timelines, and deliver under tight deadlines and high-pressure conditions.
- Have basic computer proficiency, including Microsoft Word, Excel, PowerPoint, and Outlook.
- Demonstrate effective written and verbal communication in English.
Responsibilities
- Serve as the FDA point of contact for assigned development programs and coordinate regulatory communications.
- Co-lead cross-functional Biologics License Application (BLA) submission efforts, coordinating contributions and timelines across functions.
- Serve as regulatory strategist and regulatory project lead or co-lead for assigned projects.
- Develop and implement U.S. and global regulatory strategies for assigned projects.
- Serve as subject matter expert for clinical modules in regulatory filings.
- Monitor and interpret new policies and guidance from FDA and other health authorities and assess their impact on assigned programs and company business.
- Coordinate document preparation and interactions with other health authorities as assigned.
- Coach and mentor junior staff supporting the Regulatory Affairs team, as needed.
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