Hobson Prior are looking for a Global Regulatory CMC Lead (Biologics) to join a leading biopharmaceutical company on a permanent basis in Slough.

Job Responsibilities:

• You will define the strategy, planning and preparation of CMC documentation and sections for regulatory submissions from a global perspective to achieve timely approvals to meet business needs.
• Manage direct reports or coach & mentor the staff members and provide input to internal GRA-CMC initiatives and/or cross functional work streams as assigned by the GRA Leadership Team.
• You will lead and ensure adequate provision of regulatory CMC input to all Health Authority interactions on CMC matters in all regions, as agreed with the GRA-CMC and GRA Leadership Teams and the Global Regulatory Lead.
• Accountable to lead or provide input to internal regulatory business initiatives and cross functional work streams as assigned.
• Provides regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs Teams and Technical & Supply Operation Teams) and advises on best practices and/or supports Commercial Teams, as assigned by the GRA-CMC Leadership Team.

Key Skills:

• Ability to build relationships and collaborate with people and teams both internal and external to the organisation.
• Successfully defines regional CMC regulatory strategy with global mind set and plans, coordinates delivery of related tasks and objectives.
• Can effectively communicates verbally and in writing in an open, honest and constructive manner while actively listening and empathizing with others.
• Capability to overcome obstacles, drive execution and deliver timely results for products in assigned regions and for departmental projects, as assigned.

Requirements:

• A minimum of 10 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.
• Ideally 8 years of experience in Regulatory Affairs CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
• Track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products.
• Extensive experience of participating in regulatory agency meetings on CMC matters.
• Knowledge of GMP requirements and standard systems (e.g. change management systems and tools).
• Demonstrated competence in people management and development.

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.