Specific activities and responsibilities:

  • Review the drug product dossier section (specifically 3.2.P.2 and 3.2.P.3) as per the EU regulatory requirement.
  • Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms.
  • Project coordination and management skills
  • CMC regulatory requirements for other than EU and US region

Required education :

Degree in relevant life science discipline

Required experience :

10-14 years of relevant experience

Required technical skills :

  • Prepare and review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Define strategies for writing documents
  • Defines positioning for variation files
  • Evaluation for the conformity of CMC documents according to the state of the art, current guidelines, local requirements, and customer directives by performing a gap analysis of regulatory documents.
  • Advise on pharmaceutical development: analysis of validation, formulation, or stability reports.
  • Advise strategies for validation, stability plan, and/or bioequivalence.
  • Regulatory compliance: ability to compare analytical techniques and/or manufacturing processes between the MA dossier and factory procedures.
  • Carry out training sessions in CMC regulatory affairs.
  • Lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Assisting with license applications as required.
  • Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of Marketing Authorisation Applications
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Ensuring compliance with the regulations of the assigned Countries within EU and US Region
  • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget

Additional experience and/or skills :

  • Experience with M3 3.2.S and 3.2.P and specifically good knowledge of 3.2.P.1, 3.2.P.2, and 3.2.P.3 would be an advantage.
  • Experience in other EU/International regions would be beneficial
  • Previous experience in people management/coordination would be an advantage
  • Good IT skills/knowledge
  • Good organizational skills
  • Good communication skills
  • Pro-active attitude and ability to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work
  • Hands-on experience of product launches within EU and US region

Regulatory Affairs Specialist – CMC 215

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