Regulatory Affairs Project Manager
Key Skills
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 [email protected] to learn more.
Core Responsibilities
Lead global regulatory programs and coordinate cross-functional teams. Ensure high-quality regulatory deliverables from product development through lifecycle management.
Requirements
Requires at least 7 years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Project Management, along with strong stakeholder and client management skills and experience with global submissions, lifecycle management, and CTD/eCTD dossiers. CMC experience is strongly preferred; consultancy, CRO, or regulatory services experience is a plus, and a bachelor's or master's degree in a relevant life sciences discipline is specified.
About Celegence
Industry: Business Consulting and Services
Company size: 51-200 employees
Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy. We aim to help Life Sciences companies navigate complex global regulatory requirements by providing depth of experience and an extensive delivery capability. As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence. Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day-to-day operations. Celegence is a privately owned business headquartered in Chicago, IL with offices in the U.K., Europe, and Bangalore(India).