Senior Manager - CMC

Proclinical is working with a leading Pharmaceutical company that is seeking a Senior Regulatory Manager, CMC to be based in Reading on a permanent basis. Reporting to the Director of Regulatory Affairs CMC, the Regulatory CMC Senior Manager is accountable for implementing regulatory strategy, delivering high quality regulatory submissions, and managing regulatory compliance activities throughout products' life cycle. This role will serve as the global regulatory CMC lead for one or more programs. This position reports to a Director of Regulatory Affairs

Job Responsibilities:

• Lead development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals
• Manage preparation, review, and completion of high-quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, agency meetings and other regulatory documents to product life cycle management
• Manage regulatory compliance activities including periodic regulatory reporting, change control assessments, review of technical documents, and deviations as related to the assigned program(s)
• Manage timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
• Provide support to regulatory interactions on CMC related topics.
• Actively participate in RA CMC infra-structure and capability building.
• Mentor junior regulatory CMC staff and/or interns

Skills and Requirements:

• Bachelor's or master's degree in sciences with a minimum of 5-7 years of pharmaceutical/biotechnology industry experience and 4+ years of regulatory experience
• Direct experience in preparation of regulatory submissions including INDs/CTAs, briefing documents, and/or NDAs. Familiar with CTD structure and content.
• Knowledge and understanding of US, EU, Canada, and ICH guidelines. Understanding of international CMC requirements is a plus.
• Must be able to apply practical scientific understanding of analytics, manufacturing processes, and quality systems to ensure compliance with applicable regulations and guidelines.
• Strong communication skills are required for successful interactions with teams, partners, and regulatory agencies to facilitate review and approval of submissions.
• Demonstrated strength and ability to work and collaborate effectively and flexibly with multiple disciplines and personalities.
• A high level of professionalism, efficiency, and commitment.
• Effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks and work under time pressure.
• Scientific writing and editing skills.
• Clear alignment with the company's Core Values
• Highly computer literate

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44 203 078 9544 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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