Hobson Prior are currently seeking a Global Regulatory CMC Scientist (Biologics) to join a top global biopharmaceutical organisation focused on changing the lives of patients living with severe diseases. You will join them on a permanent basis in Slough.

Job Responsibilities:

• You will be responsible for developing and executing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
• You will manage CMC projects yourself and writing regional and global CMC documentation for submissions (CTA, MAA/BLA/NDA, Variations, supplements) in line with agreed global regulatory strategy, and within agreed timelines.
• Accountable for regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Track wise, UPILOT, etc.) within defined timelines.
• You will ensure effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Teams, Technical & Supply Operations Teams, Development and Commercial Teams as agreed with the Global Regulatory CMC Lead.
• Recognising supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.

Requirements:

• You will be educated to a master's level, in a relevant life science or business-related discipline.
• Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.
• Several years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity.
• You will have relevant experience in Regulatory Affairs CMC and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.