Regulatory Affairs
17 hours ago
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.: Review artworks and promotional materials in collaboration with Production and Commercial team
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
Regulatory CMC Officer / Regulatory CMC Executive / Regulatory CMC Associate / Pharmaceutical / Biopharmaceutical / Regulatory CMC / MAA / eCTD / Labelling / Variations
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