MSD

Senior Specialist Regulatory Affairs CMC

MSD

contract

Posted on:

Location Type: Hybrid

Location: Schwabenheim • Germany

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Job Level

Senior

About the role

  • Collaborate cross-functionally with Manufacturing, Quality, Technical Support and R&D, in close coordination with the primary CMC AD responsible for the project
  • Work with the project team, CORAs and the CMC AD to ensure all critical CMC aspects are addressed
  • Support the development and maintenance of standard processes and systems to manage regulatory information and ensure regulatory compliance
  • Participate in complex projects related to these processes or systems as required
  • Maintain and apply in-depth knowledge of EMA, FDA, VICH and other country-specific CMC/quality guidelines for pre- and post-approval CMC submissions
  • Provide documentation to countries, including creating and maintaining the corresponding documents and binders in Alexx submissions
  • Support the senior CMC AD during the LOQ-A phase (e.g., by tracking timelines and deliverables)
  • Assist the CMC project team with activities such as gap and risk assessments and kick-off meetings (CORAs)
  • Verify submission or registration status with CORAs and compile required variations for countries prior to launch if relevant changes occurred during US or EU registration to ensure compliance
  • Participate in new product development teams and other cross-functional teams

Requirements

  • Bachelor's degree (B.Sc.) in Pharmacy, Chemistry, or a related scientific discipline
  • Experience preparing CMC sections in the Common Technical Document (CTD) format
  • Experience preparing US supplements and EU variations
  • Proven ability to critically review detailed scientific information
  • Good understanding of related areas (Manufacturing, Analytical, Quality Assurance, and R&D)
  • Strong written and verbal communication skills in multicultural settings
  • High level of professionalism
  • Proficient in English
Benefits
  • Flexible work arrangements: Hybrid
  • Opportunities for professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC sections preparationCommon Technical Document (CTD) formatUS supplements preparationEU variations preparationregulatory compliancegap assessmentsrisk assessmentsdocumentation creationproject managementscientific information review
Soft Skills
cross-functional collaborationstrong written communicationstrong verbal communicationprofessionalismmulticultural communicationcritical thinkingorganizational skillsteamworkproblem-solvingattention to detail