Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): 0 - 20,000
Regulatory Affairs Manager - CMC Europe: 12 months. Location: Uxbridge or Cambridge Rate: £60 - £75 per hour Regulatory Professionals have been tasked by a leading biotech firm to recruit on their behalf a Regulatory Affairs Manager within CMC
Regulatory Affairs Manager - CMC Europe
Duration: 12 months
Location: Uxbridge or Cambridge
Rate: £60 - £75 per hour
Regulatory Professionals have been tasked by a leading biotech firm to recruit on their behalf a Regulatory Affairs Manager within CMC to operate out of either Cambridge or Uxbridge.
The role will entail that the regulatory professional play a key role in developing and executing CMC regulatory Strategies for New Marketing Authorisation Applications and throughout the whole product lifecycle for the European and extended European regions.
The remit of the successful applicant will involve, but will not be limited to :
* 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 clients 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)
The optimal Background for the successful Regulatory Manager will involve:
* CMC- 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
* Experience with national legislation and regulations relating to medicinal products
* Understanding of drug development Scientific / Technical Excellence
* Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
* 5-7 years related experience within Regulatory Affairs
* BS (MS or higher preferred) life sciences, engineering or related field
* Eligible to work in the UK.
Keywords: Biotechnology, Biotech, CMC, MAA, regulatory Affairs, EU, manager, Senior Manager, Buckinghamshire, Cambridgeshire, Berkshire, Uxbridge, Middlesex, Hertfordshire, London
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