Regulatory Manager FTC

Regulatory Professionals
London (Greater)
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Regulatory Manager FTC
Maternity Cover FTC
London Based

Job Ref: J31304

This international speciality pharmaceutical company who focus on generic pharmaceutical products are actively looking for a Regulatory Manager on a maternity leave cover to be office based in Central London. This client is looking for an experienced individual to support the new product team and ensure the completion of regulatory requirements and timely completion of Marketing Authorisation Applications (MAAs).

Main Responsibilities:
* Timely submission of MAAs for new product projects, including in-licensing, new product developments and registered products into new markets.
* Prepare regulatory submission strategy for all new products.
* Liaising with Regulatory Authorities to facilitate new product submissions.
* Relationship building with new partners and their Regulatory teams to ensure efficient response to queries.
* Provide insight and opinion on risks to the Business Development Team when evaluating new products.

Application Requirements:
* Bachelor`s degree in relevant scientific discipline
* At least 4 years pharmaceutical industry experience
* Experience in preparing CTD dossier
* Broad understanding of Regulatory requirements in EU markets
* Previous experience of compiling and submitting initial MAAs
* Use of electronic portals for dossier submissions and working knowledge of Regulatory IT systems

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then you`ll receive £250 worth of vouchers of your choice.

Regulatory, New MAA, EU, Europe, New Product Strategy, submissions, CTD, electronic submissions, London, Central London, Pharma, Pharmaceutical, Middlesex, Regulatory Affairs, Regulatory Manager