Regulatory Manager - CMC
An international staffing and recruiting company is currently recruiting a Regulatory Manager - CMC 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. This will be a contract role.
- Ensuring CMC regional issues that impact global regulatory strategy for proposed CMC filings are considered and identifying risks with appropriate contingency strategies.
- Reviewing the preparation of M2 and 3 CMC components of filings and assessing fitness of purpose for submission in the relevant countries.
- Managing 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.
- Providing input 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.
- Providing regulatory input on regional regulatory mechanisms to optimise product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use, and paediatric plan).
- Gathering, consolidating, and analysing regulatory intelligence for the EU region and supporting its application to product-specific activities.
- Acting as a Point of Contact with local country regulatory staff.
- Project managing submissions and monitoring status of applications.
- Communicating regional needs for ensuring that the 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 providing advice on regional considerations.
- Maintaining an awareness of new and developing legislation, regulatory policy, and technical Regulatory guidance relating to company products.
- 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; raising resource constraints.
- Documenting and communicating details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant senior management.
Skills and Requirements:
- 5-10 years related experience within Regulatory Affairs.
- In-depth experience of pharmaceutical/biotechnology or medical device industry.
- Strong record of related experience within Regulatory Affairs (at least 7 years).
- Specific regulatory knowledge & experience within biotechnology.
- Direct experience with EU and EM market applications - MAAs or variations.
- Good understanding and direct experience of ex US filings.
- Creation and execution of regional regulatory strategies - MAAs or variations.
- Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products.
- Regulatory knowledge in regional legislation.
- Working with policies, procedures, and SOPs.
- Experience with national legislation and regulations relating to medicinal products.
- Understanding 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.
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
- 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.
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 Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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