Regulatory Affairs Manager- CMC

  • Salary: Competitive
  • REF Number: 00034476
  • Consultant: Mary Tilston
  • Contact: 01438 768717
  • Date Published: 23.11.2015
  • Closed Date: 24.02.2016
  • Sector:
  • Location: Dublin,
  • Discipline:

Mary Tilston at CK Clinical is recruiting for a Regulatory Affairs Manager- CMC to join a company in the pharmaceutical industry at their site based in Dublin on a contract basis.

The main purpose of the role will be:

  • To manage the authoring and review of CTD components of marketing applications for post approval supplements and variations.
  • To provide input into the development and implementation of CMC regulatory strategies and activities as well as managing and maintaining regulatory strategies, tools timelines and dashboards.
  • To provide regulatory advice and strategic guidance to technology transfer teams and regional regulatory teams to ensure robust content of the CMC components of the supplements.

Further responsibilities will include:

  • To manage the compilation of country specific documents required in support of supplements.
  • To co-ordinate the meetings of the global regional teams to discuss strategies and resolve issues.
  • To participate in technical transfer teams and global regulatory teams as required.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or above in life sciences or a related field.-Good experience in CMC within regulatory affairs and experience in manufacture, testing (QC/QA or clinical) or distribution in the biotech/pharma industry.
  • Proven project management skills and success in working with cross-functional teams.

This is an excellent opportunity to join a multinational pharmaceutical company that is a leader in biotechnology with an exciting pipeline of products.

For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email Alternatively, please click on the link below to apply online.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34476 in all correspondence.

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