Manager, Regulatory Affairs

Overview
- The Manager, Regulatory Affairs represents Regulatory Affairs on cross-functional teams, supporting corporate and departmental objectives.

Essential Functions and Responsibilities
- Manage planning, compilation, QC, and submission of INDs, BLAs, and amendments.
- Prepare routine IND and CTA amendments.
- Coordinate with submission authors and reviewers to ensure complete source document planning and on-schedule approvals.
- Provide regulatory expertise to cross-functional teams.
- Assist in developing and managing Gantt charts and trackers for submission timelines across multiple products.
- Maintain logs of IND/CTA submissions and correspondence with FDA or other regulatory agencies.
- Prepare templates/shells for specific submissions per company standards.
- Adhere to company core values, policies, procedures, and business ethics.

Required Education, Skills, and Knowledge
- BA/BS in a related field.
- 8+ years regulatory affairs (or related drug/biologic development experience) with a Bachelor’s; 6+ years with a Master’s; or 4+ years with a PhD.
- Experience managing regulatory submissions to global health authorities in eCTD format.
- Broad understanding of international drug/biologics regulations; familiarity with ICH and regional requirements.
- Strong organizational/planning skills; ability to influence/negotiate professionally with internal teams and external partners.
- Advanced Microsoft Office (Word, PowerPoint, Excel) and Adobe Acrobat Pro.
- High attention to detail and accuracy; excellent interpersonal and written/verbal communication.
- Comfortable in a fast-paced small-company environment; can adjust to changing priorities.

Preferred
- Advanced degree (or relevant experience).