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!
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.
- 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.
- 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.
- 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.