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CMC Writer - Larne - £25 - £35k

Location Larne, County Antrim
Sector
Job Type Permanent
Salary £25000 - £35000 per annum + Benefits
Published 4 months ago
Start Date ASAP
Contact Craig Smart
Job Ref BLU00036455p

Job Description

CMC Writer - Larne - £25,000 - £35,000 + Benefits

We are currently working in partnership with an international pharmaceutical manufacturer to appoint an experienced CMC Writer on a permanent basis at their facility in Larne. Due to continued growth and investment this is a newly created role within a newly established team, and an excellent time to join this organisation!

Role:

Reporting to the Pharmaceutical Development Director you're responsibility will be to produce high quality CMC documents such for compilation into module 2 & 3 of the eCTD for both US & EU. You will also interact with local CMC experts in analytical, formulation and quality both verbally and in writing.

Duties:

  • Preparation of CMC elements of regulatory filings.
  • Liaise with regulatory affairs colleagues to develop authoring plans and strategic approaches to filings.
  • Plan the authoring and review of CMC Regulatory documents. Ensuring consistency among documents and maintain all submissions in a systematic way.
  • Develop, improve and implement templates for CMC filings.
  • Working in collaboration with Development CMC teams and global regulatory affairs colleagues for compilation of regulatory filings and response to regulatory agencies.
  • Create final drafts of Regulatory documents for submission to CMC team and onwards to global Regulatory Affairs colleagues.
  • Set up system for collection of comments, support the operation of the review process and creates updated draft for next phase review.
  • Critically review documents for consistency, quality and compliance with applicable regulatory guidelines.

Essential Requirements:

  • Degree in Chemistry, Pharmacy or equivalent scientific degree with strong chemistry content.
  • Minimum of 2 year of industrial experience working in a pharmaceutical industry orientated role in development or regulatory affairs.

Desirable:

  • Experience working in a cGMP laboratory environment in the pharmaceutical industry
  • Experience in the compilation of CMC modules for regulatory dossiers.
  • Knowledge of drug regulations (ICH and other governing documents US and global).

For further information please contact Craig on 02890242824 or contact your CV via the link.