Regulatory Affairs CMC Manger

  • Contract
  • Cork

Website Ref:TPM04315

Summary:
A Regulatory Affairs CMC Manger is required for a biopharmaceutical company in Cork. The incumbent will report directly to the Regulatory Affairs CMC Associate Director of the EU Reg CMC group. The successful candidate will work with the Regulatory Affairs Associate Director to support operations conducted on site.

Responsibilities:

  • Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
  • Timely compilation and management of all necessary documentation for regulatory submissions.
  • Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.
  • Liaise with U.S. and Cork teams to prepare GMP documentation to support global submissions for product registrations and/or renewals.
  • Participate in cross-functional project teams as a regulatory CMC representative for project specific discussions.
  • Ensure consistent communication within the department and with other functional areas.
  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
  • Assist in the preparation for interactions with global regulatory authorities.

Qualifications & Experience:

  • Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
  • 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D), including relevant regulatory experience.
  • The incumbent must possess technical expertise in the areas of responsibility and demonstrate effective problem solving, strong understanding of regulatory affairs submissions and management skills and the ability to prioritize multiple tasks.
  • The position requires knowledge and experience in biologics and/or pharmaceuticals.
  • Experience engaging in the external regulatory & pharmaceutical environment is preferred.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.