Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): Negotiable
Manager Regulatory Affairs CMC Location: Ulm, Germany Rate: Up to €90,000 per annum (dependant on experience). Our client is a market leader within the pharmaceutical industry, producing high quality medicines across the globe.
Manager Regulatory Affairs CMC
Location: Ulm, Germany
Rate: Up to €90,000 per annum (dependant on experience)
Our client is a market leader within the pharmaceutical industry, producing high quality medicines across the globe. They are looking for a Regulatory Affairs CMC Manager to join their rapidly growing team. This is an exciting opportunity to work within a leading international generics provider.
As Regulatory Affair Manager CMC your role will include though not be limited to:
*Working closely with authors of dossier sections
*Prepare, review and approve CMC regulatory filing to health authorities; including LATAM, EMEA and APAC
*Provide regulatory guidance to project and product teams
*Develop global strategies for submission of Chemistry, Manufacturing and Controls (CMC) elements of client products
*Evaluate change requests in the change control process
*At least 2 years professional experience with regulatory submissions, drug development, manufacturing control of drugs/biologics.
*Proven experience in filing of major submissions in EU (US desirable)
*Experience of CMC related regulations in EU, US, LATAM, APAC and EMEA
*Experience in working with eDMS systems, regulatory databases, document formatting and archiving and maintenance in accordance with electronic submissions
*Excellent verbal and written English
*University Degree in Pharmaceutical Science, Chemistry, Biochemistry, Biotechnology, or equivalent.
If this role is not for you, but you know someone who is looking then please send their details to firstname.lastname@example.org at Regulatory Professionals we are a referral scheme of €250 worth of vouchers for anyone you recommend that we then place *terms and conditions apply
Key words: Regulatory Affairs, CMC, Regulatory Manger, EU, US, LATAM, EMEA, APAC, generics, submission, regulatory guidance, Germany.
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