SRG are currently looking for a Regulatory Affairs Associate Director for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Cambridge or Macclesfield (with some flexibility for remote working).The Role: To proactively partner 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. Will lead and/or deliver regulatory CMC components of business related projects across functions, of high quality, consistent and complete, as agreed for the Product strategies. May provide effective RA CMC representation on a variety of development product teams Will input to and support progressive strategic, tactical or operational, regulatory CMC expertise and direction to Company Global Reg project teams. Will have a high level of interactive communication and support the direction for the team, working flexibly with the team. Has good understanding of need for cultural sensitivity. Will support managing high level risk by looking at regulatory options and working with the team to make complex judgements, developing innovative risk based solutions and applying progressive comprehensive cross-functional and industry understanding.Key Responsibilities: Support regulatory representatives on assigned project teams. Support application of progressive thinking and regulatory CMC expertise to TA and non-TA projects within company RA and company technical functions and help develop innovative regulatory strategies globally. Will typically have responsibility for development projects for new biologics, other modalities and post approval product support Project manage to ensure project activities and documentation are delivered to a high standard, agreed time scales and meet company 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 company RA for assigned projects. Such submissions are clinical trial applications (IND, CTA, etc), marketing authorisation applications (NDA, MAA, JNDA etc), line extensions, or post approval activities. The applications may be global in scope. Plans, coordinates, prepares, and supports meetings with regulatory agencies. Working with the Reg CMC team to provide company 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. As agreed with Project lead, works with marketing companies, manufacturing sites and relevant technical functions such as BPD, GTO or Quality as appropriate for assigned projects. May act as key contact for identified customer functions to facilitate high quality partnerships with customers. Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. Register, Angel etc. Skills/Experience Required: 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. 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. Proven Project management skills. Ability to interpret, understand and effectively communicate regulatory application procedures and specialist knowledge in worldwide regulatory CMC requirements for development, license maintenance and renewal submissions and ability to help others understand these. Effective in a highly matrixed organization and able to manage external business partners Critical thinking/Problem solving: Deals with a wide range of problems that require complex judgements and innovative solutions. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: email@example.com or +441615077288.
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