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Regulatory Affairs Senior Manager - International CMC

Employer
Compass Life Sciences
Location
Uxbridge, London (Greater) (GB)
Salary
75,000+
Start date
23 Sep 2022
Closing date
23 Oct 2022

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

Regulatory Affairs Senior Manager - International CMC 
Uxbridge or Cambridge - Hybrid 
£75,000 - £85,000 
  
Compass Life Sciences have partnered with a global leading Biotech to support them in their search to appoint a Regulatory Affairs Senior Manager - International CMC, to join their International Regulatory CMC Centre team. The successful applicant will be someone who can develop and execute CMC regulatory strategies for new Marketing Authorization Applications, Clinical Trial Applications, and Post-approval Variations dossiers that comply with international country/region regulatory standards. Additionally, this role will require close collaboration with the Centre Director for International Regulatory CMC, International CMC leads as well as country local Regulatory representatives to ensure efficient execution of the regional submission plans. 
  
Key Responsibilities
Responsibility for the generation and execution of international country specific regulatory strategies
Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals, and responses to questions across assigned products and countries for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
Review and preparation of M2 and 3 components for International Clinical Trial Applications, Marketing Applications, and post-market supplements/variations
Authoring and coordinating responses to questions across assigned products and countries.
Gathering, consolidating, and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
Project management of submissions and monitoring status of applications
Provides guidance for and performs regulatory assessments of change control requests
Provide regional/country, product & regulatory expertise, and clarification on International CMC RA requirements
 
Knowledge & Experience
Master's or bachelor's degree or equivalent
Regulatory Affairs experience
Creation and execution of regional regulatory strategies
CMC specific regulatory knowledge and experience in the manufacture/testing of pharmaceutical products
Direct experience with international market applications - MAAs or variations
Good understanding or direct experience of ex US filings
Excellent communication skills with ability to communicate across all levels
Project management skills with ability to work well with others in demanding situations
Ability to work in a fast-paced environment
Current knowledge and application of CMC hot topics and knowledge of international legislation and guidance for biotechnology products
Strong MS Office skills
 
Competitive salary reflecting experience and ability. Benefits include a generous car allowance, Long Term Incentives (LTI) and Bonus. This role offers the ability to work flexibly from home with regular office work from one of two next generation workspaces. 
  
Contact details 
If you are interested in learning more, please contact me directly today as we are looking to appoint as soon as possible. For further information please contact me at cscott@compassltd.co.uk, or phone +44 (0)239 4211142. 
  
Referrals 
Not right for you but, know someone who would be interested? Why not refer a friend? Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer up to £/€1000 worth of Amazon Vouchers for each successful recommendation.

Company

Compass Life Sciences was formed in 2018 by veteran recruitment professionals. Candid conversations with Investors and clients identified a demand for highly knowledgeable, experienced, quality-based recruitment solutions within the sector that offered a genuine, consultative service.

Our capabilities have grown in line with our team’s headcount; and we now serve a wide range of key specialisms including R&D, Clinical Research, Commercial Operations, Data & Bioinformatics, Regulatory Affairs and Medical Affairs. We have been consistently commended for offering the highest levels of knowledge-based recruitment solutions to both candidates and clients.

We believe that the future of recruitment is firmly rooted in ingrained partnerships, where a more proactive and strategic relationship is important. As Compass Life Sciences continues to move forward, we will endeavour to provide the highest quality, valued solutions in all our relationships.

Differentiated by quality and knowledge, Compass Life Sciences has been born out of the desire to raise the standards of Life Sciences recruitment in the UK and Global markets.

As a team, we are proud to be able to evidence experience working in the Pharmaceutical, Biotech and Supplier & Vendor industries, ranging from University Placement Years, through to onsite Talent Acquisition employment, which has provided our fundamental understanding of the specialisms we recruit both for, and into

Find Us
Website
Telephone
02392 384555
Location
Admiral House
8a, High Street
Cosham
Portsmouth
PO6 3BZ
United Kingdom
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