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Regulatory Affairs Manager

hiring now

Aerotek

2021-12-03 07:36:44

Job location London, Greater London, United Kingdom

Job type: fulltime

Job industry: Government & Defence

Job description

Exciting Regulatory Affairs opportunity, outside IR-35, at one of the world's leading Pharmaceutical companies!

They are looking for someone with profound submission management experience to join their Regulatory team as Regulatory Affairs Manager.

The key responsibilities of this role include:

* Provide regulatory expertise on submission delivery strategy of all dossiers and all application types

* Lead and / or contribute to the planning, preparation, and delivery of submissions throughout the product's life cycle from either a global and/or regional perspective.

* Develop, execute, and maintain submission delivery plans, submission content plans, and be the point of contact for designated clients

We're looking to speak with any candidates that have:

* 5+ years' regulatory experience within the biopharmaceutical industry, or experience at a health authority

* Experience with submissions: New Drug Application (NDA), Initial Marketing Authorisation Applications (Initial MA) and Life Cycle Management (LCM) initiative

* Strong project management and submission strategy experience

* Experience working on Oncology products

* Experience working with the US region

This is an initial 12-month contract with the potential for extension. The role is paying competitive rate outside IR-35, and can be 100% remote working, but do prefer some travel to the site in Cambridge.

If this sounds like the ideal role for you, please send your CV to [](mailto:). If this does not sound like the right role for you but you know someone that could be right, please forward on a method of contact to this person and you could be eligible of a referral fee. Also, we have a variety of roles that could be of interest but might not be advertised due to NDAs so please do feel free to send over your profile and we will be in touch with relevant positions.

Regulatory Affairs, Project management

Regulatory submissions, regulatory strategy

Outside IR-35, FDA

Oncology, submissions

Marketing Authorisation (MA)

New Drug Application (NDA)

Inform a friend!

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