Site Regulatory Compliance Manager
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.
The Merck Aubonne site is recruiting its Site Regulatory Compliance Manager to support its ongoing product growth and site expansion.
Reporting to the Site Quality Director, the job holder is responsible for:
- Managing a team of Regulatory Compliance Specialists
- Ensuring alignment of local manufacturing activities and GMP documents with regulatory filings.
- Coordinating the provision of regulatory deliverables to support regulatory submissions (CTD, IND, IMPD) and Answers to Objections.
- Writing some Technical Regulatory documentation
- Assessing all changes arising from site activities and projects
- Providing local expertise in regulatory compliance and CMC regulatory affairs
- Constituting the respective sites local point of contact for Merck Serono Global Regulatory Affairs CMC and for Health Authorities.
- Maintaining the site manufacturing authorization(s), provision of related Health Authority certificates,
Who you are:
- Pharmaceutical / Biotech / Medical Device industry professional with at least 10 - 15 years experience
- Graduate degree or more in a scientific or engineering discipline.
- Expertise in CMC Regulatory requirements for EU / US / China / Japan.
- Good knowledge of all technical aspects of biotech / sterile / combination products
- Leadership with good communication and management skills
- Excellent organization and analytical skills
- Fluent in French and English. German or Italian a plus.
What we offer:Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
Curious? Apply and find more information at come2merck.com