An excellent opportunity has arisen for an experienced CMC specialist to join a CRO on an initial 6-12 month contract basis. Excellent rates and 100% home working are on offer! Previous biologics experience is ESSENTIAL for this role.
*Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval
*Develop global Regulatory CMC strategies for client's biologics products to facilitate overall program goals.
*Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers as required in order to ensure alignment of development and implementation of activities with overall regulatory CMC strategies.
*Actively manage complex CMC regulatory submissions and ensuring quality and timelines are met for all pre and post approval biologics submissions.
*Manage regulatory CMC aspects of post approval change controls, liaising with stakeholders to ensure regulatory compliance. Responsible for recommending the appropriate regulatory reporting mechanism, in liaison with regional regulatory experts.
*Lead the preparation of CMC aspects of documents for regulatory agency interactions and may represent Regulatory CMC in agency meetings.
*Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
*Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance for biologics, and provide regulatory advice to project teams
*Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
*A minimum of a graduate degree in Life Sciences
*Candidates with experience in pre and post approval biologics CMC, including for monoclonal antibodies, insulin products regulatory filings.
*Biosimilar experience would be an advantage
*Significant knowledge on Biologics regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
*Significant knowledge of ICH guidelines and BLA submission requirements of various markets such as USFDA, EMA etc.
For further details, please contact Tim Barratt on 01727 817626 or send a copy of your CV to email@example.com