Manager of Regulatory Affairs
On-siteMason, Ohio, United States
Job Summary
Prepare, review, and submit regulatory filings including NDAs, ANDAs, annual reports, and supplements while tracking status updates for drug product registrations. Develop submission timelines, eCTD content plans, and tables of contents to ensure consistency with US and international regulatory requirements. Author and manage IND, NDA, PAS, and AR submissions alongside adverse event reporting and labeling/promotional material approvals. Stay current with FDA regulations and emerging guidance to inform regulatory strategies and support business objectives. Review technical protocols, change controls, and GMP documents for compliance and quality. Collaborate with cross-functional teams on projects and manage outsourced pharmacovigilance activities. Work days with potential extended hours and weekend coverage; up to 10% travel required.
Required Qualifications
- Minimum 6 years of prior experience working in the pharmaceutical industry or equivalent process-related industry
- Working knowledge of cGMPs (current Good Manufacturing Practices) and FDA (Food & Drug Administration) pharmaceutical regulations
- Strong familiarity with MSOffice
- Strong command of internet search tools and techniques for research-related responsibilities
- Good time management with demonstrated ability to manage multiple priorities simultaneously
- Able to operate successfully in a team environment
- Strong interpersonal and influencing skills to participate and/or lead (as needed) cross-functional teams, successfully challenging them to work collaboratively on solutions and meet project deadlines
- Ability to sit for extended periods at a desk
- Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, steel toe shoes)
- Good eyesight to tolerate extended viewing of computer screen
- Good manual dexterity to operate computer, keyboards, and general office equipment
- Position may require up to 10% travel
- This position works days, but may include extended hours and weekend work when required
Desired Qualifications
- B.S. degree in Biology, Chemistry, or Allied Health Sciences
- M.S. degree in Pharmacy (or a related scientific field) or M.P.H.
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