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Manager Regulatory Affairs - office or home based

Job Field:
Clinical Research Jobs, CRM (Clinical Research Management) Jobs, Regulatory and Drug Safety Jobs
Clinical Project Manager Jobs, Clinical Team Manager Jobs, Drug Safety Jobs, Regulatory Affairs Jobs
United Kingdom
All England
Contract Type:
Salary Description:
Job Ref:

Manager Regulatory Affairs - office or home based

This role is a great opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world’s leading CRO. This position requires a demonstrable knowledge of operational experience in European regulatory within the service industry, e.g. a CRO, BPO or similar.

Our Regulatory Affairs Department works on global projects and covers all regions. We work on a variety of therapeutic areas and support the biggest pharma companies as well as smaller organizations. You will join a global team that thrives on teamwork and collaboration. Our organization is looking to grow in new projects and expand the scope of strategic regulatory work.

Your responsibilities will include:
• Prepare Scientific Advice Packages / Meeting with authorities, PIP submissions, ODD submission and/or coordinate MAA submissions
• Project management oversight of a European or Global regulatory team
• Effective interaction and meetings with Regulatory Agencies and Clients
• Project-level responsibility to stay within budget, complete work on-time and quality deliverables for projects
• Provide strategic insights to support the European team

This is a billable role, therefore expertise to conduct billable project work is required, preferably in the regulatory strategy, pre-MAA area

Skills and Experience required:
• Have significant experience working in the service sector of Regulatory Affairs (6+ years) in particular
• You should have hands on experience of all or some of the following areas:
EU Marketing Authorisation Applications
Post authorisation submissions (variations, renewals, transfers etc.)
Scientific Advice
Orphan Drug Designations
Paediatric Investigation Plans
Ideally have regulatory experience and expertise in the preparation and submission of MAAs, PIPs and ODDs
• Excellent communication and organisation skills
Track record in supporting successful drug development and registration

• Scientific degree - Pharmacy, biotechnology, chemistry or life science. Higher degrees would be more desirable
• 6+ year’s regulatory affairs operational experience, ideally within the service sector (CRO, BPO, etc.)

Closing Date:

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