Senior Regulatory Affairs CMC (ATMP / Small Molecules) -Munich
📋 Role Overview & Responsibilities
Our client is a well-known global regulatory consulting firm with over 15 years of experience and a stable work environment. With plans to grow the team from 45 to 80 members in the next two years, this is an exciting opportunity to join a successful and expanding company.
Benefits
Relocation assistance to Munich (incl. Visa support)Competitive compensation and a friendly, collaborative work cultureBase salary + paid per hours consulting
Responsibilities
Offer authoritative guidance to clients on regulatory affairs concerning drug development and regulatory compliance.Ensure that CMC packages and documentations are compliant with regulatory standards and poised for submission approval.Prepare comprehensive submissions including MAA, BLA/NDA, IMPD, and IND.Conduct thorough gap analysis of client packages, pinpointing development and strategy issues.Organize and lead meetings with regulatory agencies and clients.Provide advice on both operational and strategic aspects for companies.Oversee operational and strategic functions with Contract Development and Manufacturing Organizations (CDMOs).Stay abreast of changes in regulatory requirements.
Requirements
Hold a PhD in a Life Science field (e.g., Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology).Possess a minimum of 10 years’ experience in pharmaceutical regulatory affairs with a focus on CMC.Demonstrated experience with ATMP or Small Molecules is essential.Proven track record with regulatory filings.Fluent in English; proficiency in German is advantageous.Willingness to relocate to Munich.
If you are interested in this position, please apply here or send your resume to me, Larissa Lauricella, on the NonStop Consulting website or through my LinkedIn profile. If you are not available but know someone who might be interested, please forward this message to them and support the people in your network. [email protected] .
DE: +49 893 704 0117
Internal Extension: 6493
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