Regulatory Affairs Manager

An international staffing and recruiting company are currently recruiting a Regulatory Affairs Manager to join their office in the UK. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.

The Regulatory Affairs Manager will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and whole product lifecycles for the European and extended European region.

Job Responsibilities:

• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Reviewing the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Managing Strategy and Execution for all regulatory submissions (e.g. clinical trial and variations)
• Authoring and coordinating responses to questions across assigned products and countries.
• Acting as Point of Contact with local country regulatory staff
• Project management of submissions and monitoring status of applications
• Communicating regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
• Ensuring regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
• Sharing regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
• Performing regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Providing guidance for regulatory assessments of change control requests
• Setting project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
• Documenting and communicating details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant sr. management site.

Skills and Requirements:

• 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.
• Understanding of drug development Scientific / Technical Excellence
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.
• Strong team player with a commitment to customer service
• In-depth experience of pharmaceutical/biotechnology or medical device industry
• Strong record of related experience within Regulatory Affairs (min 5 years)
• Good understanding of quality management systems.
• Demonstrable knowledge of current UK/EU regulatory framework for medicinal products.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Peter Duvall at +44 203 078 9542 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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