Walker Cole International is searching for a Regulatory CMC Officer to join a large European Biopharmaceutical company based in South East of England. As a Regulatory CMC Officer, you will be responsible for performing regulatory affairs activities such as participating in the lifecycle of existing MAs world-wide & preparing CMC modules for new MAAs.
Your responsibilities as the Regulatory CMC Officer will be:
- Prepare and compile regulatory submissions for European and non-European territories in line with regional and local requirements and scientific and company policies and procedures
- Prepare high quality CMC documents and packaging components for assigned regulatory submissions (e.g.: MAAs, responses to deficiencies, variations, CMC agency communications)
- Review artworks and promotional materials in collaboration with Production and Commercial team
- Effectively prepare safety variations including the review of SmPC's and subsequent updates to PILs
To be a successful candidate for the Regulatory CMC Officer role:
- Minimum of 3 years in the regulatory pharmaceutical field
- Proven regulatory affairs knowledge, including demonstrated experience in post-approval MA maintenance (CMC and labelling)
- Knowledge of current CMC regulatory requirements, including ICH requirements, relevant technical quality guidelines, EU requirements and GMP standards
- Experience dealing with EU agencies on quality related matters
- Basic knowledge of eCTD standards
Regulatory CMC Officer / Regulatory CMC Executive / Regulatory CMC Associate / Pharmaceutical / Biopharmaceutical / Regulatory CMC / MAA / eCTD / Labelling / Variations