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Regulatory Affairs Principal, Pharmaceutical and Combination Products
Meridian Bioscience Inc.Regulatory Affairs Principal providing strategic leadership for pharmaceuticals and combination devices at Meridian Bioscience. Involves interactions with FDA, approval processes, and regulatory strategy.
About the role
Key responsibilities & impact- Provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products
- Serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy
- Author and review INDs, NDAs, supplements, and other global regulatory submissions
- Develop and deliver high-quality briefing documents, responses, and regulatory communications
- Provide regulatory guidance on clinical, nonclinical, and CMC development activities
- Drive combination product regulatory strategy, including coordination with FDA’s Office of Combination Products (OCP)
- Advise on labeling strategy, including prescribing information and device components of combination products
- Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways
- Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)
- Stay current on evolving regulatory requirements and translate them into actionable guidance for teams
- Mentor and provide guidance to junior regulatory team members
Requirements
What you’ll need- 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products
- Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements
- Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution
- Experience with combination products (drug-device) strongly preferred
- Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance
- Exposure to global regulatory environments (e.g., EMA, ICH) preferred
- Bachelor's degree in a scientific discipline required
- Advanced degree (MS, PhD, PharmD) preferred
- Certification RAC (US or Drugs) preferred
- Travel 0-10%
Benefits
Comp & perks- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsFDA CDER submissionsINDsNDAsregulatory strategylabeling strategyCMC developmentglobal regulatory submissionscombination productsregulatory impact assessment
Soft Skills
strategic leadershipcross-functional collaborationmentoringcommunicationguidance
Certifications
RAC (US or Drugs)