Hobson Prior are looking for a Regulatory CMC Lead to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. As the Regulatory CMC Lead you will co-operate with Global Regulatory CMC Teams on complex global projects for new biologic or other modality, or line extensions and post approval submissions, helping to build innovative, risk based Regulatory strategies.

Job Responsibilities:

• Support regulatory representatives on assigned project teams.
• Support application of progressive thinking and regulatory CMC expertise to TA and non-TA projects within RA and technical functions and help develop innovative regulatory strategies globally.
• Responsibility for development projects for new biologics, other modalities and post approval product support.
• Ensure project activities are negotiated and delivered to a high standard, agreed time scales and meet business requirements, compliance requirements and regulatory authority expectations worldwide
• Project manage to ensure project activities and documentation are delivered to a high standard, agreed time scales and meet business requirements, compliance requirements regarding manufacturing and development and regulatory authority expectations worldwide.
• Supports the strategy for fit for purpose content of CMC submissions and review and approve regulatory CMC documents on behalf of RA for assigned projects.
• Plans, coordinates, prepares, and supports meetings with regulatory agencies.
• Working with the Reg CMC team to provide the organisation's technical functions clear, concise guidance on current CMC regulatory requirements, as well as creative thinking for alternative Reg. acceptable strategies, to support business tactical or strategic planning.
• Support recommendations and decisions being proposed on regulatory issues relating to CMC, including risk management and mitigation and communication of these.
• Participate and/or lead various multi-disciplinary teams or taskforces related to CMC/product development.
• Interact effectively with external business partners.

Key Skills:

• Self-motivated/proactive and progressive strategic thinker, who can operate independently.
• Proven track record in biotechnology/biologics CMC regulatory field.
• Strong work ethic and entrepreneurial spirit.
• Excellent written and spoken communication skills.

Requirements:

• Experienced graduate or in a scientific discipline, typically chemistry, pharmacy or a biological science.
• Knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture
• Typically, 5+ years' experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.
• Awareness of regulatory requirements and submissions pathways.
• Significant project or line management experience in a relevant environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.