Regulatory Affairs CMC Manager (m/f/x)- Bayern, Germany
package negotiable
Bayern
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Regulatory Affairs CMC Manager (m/f/x)- Bayern, Germany

We are seeking a Senior Regulatory Affairs CMC Manager to join one of our key client's team as a quality expert. This role involves providing expertise on a broad range of drug substances (small molecules, biologicals). The position covers quality-related topics from pre-clinical development through to approved commercial products.

Key Responsibilities:

  • Quality aspects of drug development and regulatory requirements, collaborating with cross-functional team experts.
  • Ensure CMC work-packages and documentation are phase-appropriate, meet regulatory expectations, and support regulatory submission approvals.
  • Prepare quality sections for MAA, BLA/NDA, IMPD, and IND.
  • Analyses, identify critical CMC development issues, and develop resolution strategies.
  • Support due diligence processes.
  • Manage operational and strategic aspects with CDMOs.
  • Coordinate filing activities within the cross-functional team and with contributing parties.
  • Stay up to date with regulatory guidance and regulations.

Qualifications:

  • Ph.D. or master's degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a related field.
  • Minimum of five years in a scientific/technical CMC development or CMC regulatory affairs role.
  • Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
  • Excellent communication and negotiation skills in English; German is a plus.
  • Familiarity with CMC and regulatory requirements from pre-clinical to Phase III or commercial stages.
  • Strong team player with excellent interpersonal skills.
  • Proficient in Microsoft Office applications.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

Email: s.revesz@sciproglobal.de

Tel: 0049 (0) 89 26 200 311 (direct dial)

LinkedIn: www.linkedin.com/in/sara-revesz-1938b2239

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