Regulatory Affairs Manager - European Centralised

For this position the successful candidate will come from a background within pharmaceuticals or scientific within Regulatory Affairs, preferably focusing on EU centralised submissions and licensing.

Main responsibilities will include:
Preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigation and commercial products in Europe, in accordance with regional requirements and scientific and company policies and procedures.
Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications in Europe and marketing authorizations for assigned territories (EU Centralised).
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.

Ideal experience:
Regulatory Affairs
Experience working with Regulatory Authorities in EU
Knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

A full specification is available, please email your up to date CV

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.