Regulatory Compliance Specialist (m/f/d)

at  Merck

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As an integral member of our Quality Unit, you will be accountable for change control assessment, compliance of manufacturing activities vs regulatory filing, provision of regulatory documents and regulatory intelligence and local expertise in RA.

• Review and assess changes reportability to health authorities and approve minor changes
• Review and approve any relevant GMP documentation against applicable regulatory filings and marketing authorizations
• Coordinate collation of regulatory deliverables (data/documents) to support regulatory submissions and assist in the Answers to Objections of Health Authorities
• Responsible for some technical regulatory writing (in CTD format)
• Coordinate local review of regulatory CMC modules of the registration file
• Bring the attention of the Site QA any new compendial or revised monographs concerning regulatory procedures or any compendia product monograph, new Health Authority guidelines or inquiry (regulation compliance) and provide support for appropriate and timely implementation to ensure compliance