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Senior Manager Regulatory Affairs (Virology Product Lead)

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2021-12-03 08:53:47

Job location Barkingside, Greater London, United Kingdom

Job type: fulltime

Job industry: Government & Defence

Job description

Senior Manager Regulatory Affairs | Virology | Conditional MAA product

Regulatory Affairs Senior Manager, Regulatory Product Lead, Regulatory Submissions, Virology, CTAs, EU, PIP, ODD

Your new company
This Multi-National biopharmaceutical company are looking for someone to join their Virology team as Regulatory Affairs Senior Manager (Product Lead). Being a part of the Regulatory Affairs Virology team gives you the opportunity to work across an innovative and fast-paced portfolio, across life-threatening diseases. This will be based in the company's Uxbridge or Cambridge site with flexible working.

Your new role
By joining the Virology team as Regulatory Affairs Senior Manager (Product Lead), you will get the opportunity to act as Product Lead on an innovative orphan drug. This is a standalone senior leadership position, working on submissions across Centralised European markets as well as Canadian, Australian and Brexit-related activities. You will be expected to cover new early-stage submissions such as CTAs and MAAs, as well as work across life-cycle maintenance as the product moves throughout the stages of the life-cycle. The life cycle maintenance work will be particularly complex, submitting Clinical, Labelling and Type II variations, Line Extensions, and Post-Market Paediatric submissions. You will act as product lead and take full ownership for a product under a conditional MAA.

Main Responsibilities

* Experience with Conditional MAA's
* Life-cycle Maintenance of a product
* Technical Regulatory Affairs strategy development
* Initial Submissions across: CTAs, MAAs, PIPs, ODDs, Labelling
* Post-Marketing Submissions across: Complex Variations, PIPs, Line Extensions, Renewals
* Independent product ownership
* Strong Labelling knowledge
* Communication with cross-functionally
* European (CP) market submissions (Mainly)
* Canada, Australia, Brexit market Regulatory submissions (Additionally)

What you'll get in return
You will get the opportunity to work with a top 10 pharma across an extremely innovative product portfolio. You will be compensated generously for the high level of responsibility of the role and have ample opportunity for progression internally. You must have the right to work in the UK.

What you need to do now
If you are interested in this role please click \"apply now\".

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