Regulatory Affairs Project Manager
Company: Celegence
- Location: Waalwijk, Netherlands
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Part-time
- Posted: 12 days ago
- Offer language: English
Job description
Company Description Celegence provides specialized services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy, helping organizations navigate complex global regulatory requirements. The company works across all phases of the product lifecycle, from regulatory strategy and authoring to established product maintenance, submission management, publishing, and health authority interactions. Celegence leverages a global team of consultants to deliver local regulatory insight, intelligence, and tailored support for diverse markets. Its mission is to collaborate with customers to improve Regulatory Affairs efficiency so they can focus on delivering exceptional patient value and maintaining worldwide regulatory compliance. Celegence is a privately owned business headquartered in Chicago, IL, with offices in the U.K., Europe, and Bengaluru, India.
Role Description The Regulatory Affairs Project Manager is responsible for leading global regulatory programs, coordinate with cross-functional teams, and ensure high-quality regulatory deliverables from development through lifecycle management.
Experience & Qualifications
- 7+ years' experience in Regulatory Affairs, Regulatory Operations, or Regulatory Project Management
- Strong stakeholder and client management skills
- Experience with global submissions, lifecycle management, and CTD/eCTD dossiers
- CMC knowledge/experience strongly preferred
- Consultancy, CRO, or regulatory services experience is a plus
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, chemistry, biotechnology or related life sciences discipline
📍 Location: Waalwijk, Netherlands (Hybrid)
⏳ Minimum 32 hours per week
Apply or reach out at careers@celegence.com to learn more.
