Regulatory Affairs Manager

One of the leading biotechnology companies in the world is seeking a Regulatory Affairs Manager to join their team in Cambridge, UK.

Job Responsibilities:

• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
• Inputs into the regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy
• Authoring and coordinating responses to questions across assigned products and countries.
• Provides regulatory input on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
• Gathering, consolidating and analysing regulatory intelligence for the EU region and support its application to product-specific activities
• Point of Contact with local country regulatory staff
• Project management of submissions and monitoring status of applications
• Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
• Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Provides guidance for regulatory assessments of change control requests
• Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
• Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant senior management

Education, Skills and Experience:

• In-depth experience of pharmaceutical/biotechnology or medical device industry
• Strong record of related experience within Regulatory Affairs (min 7 years)
• Regulatory knowledge in regional legislation
• Working with policies, procedures and SOPs
• Experience with national legislation and regulations relating to medicinal products
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.

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 Peter Duvall on +44 203 0789 542 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.