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Job Details

Associate Director Regulatory Affairs

Company: Hydrogen Group
Location: Switzerland
Reference: JO-1701-900380
Closing Date: 30 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Hydrogen Group has been appointed to search and select an Associate Director Regulatory Affairs, who is looking to contribute their expertise to facilitate and assist a regulatory team on behalf of a growing global pharmaceutical services organisation. This is a great opportunity for a Regulatory Affairs professional to develop and progress into a leading role.The role comes with an attractive salary. The position is based in one of the company's major global hubs.

Requirements:

The Hydrogen Group has been appointed to search and select an Associate Director Regulatory Affairs, who is looking to contribute their expertise to facilitate and assist a regulatory team on behalf of a growing global pharmaceutical services organisation. This is a great opportunity for a Regulatory Affairs professional to develop and progress into a leading role.

The role comes with an attractive salary. The position is based in one of the company’s major global hubs. More information on this can be given upon request. Please contact Elizabeth De Pontes on D +44 (0)20 7002 0263 or M +44 (0)78 3738 8807 or alternatively email: elizabethpontes@hydrogengroup.comAssociate Director Regulatory Affairs

As an Associate Director Regulatory, you will have the strategic function of acting in a counselling manner and accountable for managing, maintaining and supporting all regulatory activities to diverse departments in order to facilitate the organisation’s growth and success.

Responsibilities:

* Responsible for managing and coordinating regulatory activities focused on European projects
* Guarantee that all regulatory submissions are successfully assembled according to the highest regulatory standards
* Strategic cross-functional interaction with a variety of departments to provide EU regulatory solutions to problems including the management of timelines to complete regulatory submissions on time
* Responsible for providing assistance to perform effectively the planning, critical reviews and scientific writing of a number of regulatory activities such as: MAAs, INDs, changes, IMPDs. BLAs, annual reports, DSUR in order to successfully obtain the regulatory approval
* Responsible for tracking and managing accordingly to current and new regulatory standards and requirements relevant to regulatory aspects

Requirements:

* Minimum a MSc degree in Life Sciences - Ph.D. is preferred
* Substantial direct EU regulatory experience
* Over 8 years of experience in the pharmaceutical industry
* Direct experience of working with EU National Health Authorities and EMA is preferred


If you would like to discuss this role please contact Elizabeth De Pontes on D +44 (0)20 7002 0263 or M +44 (0)78 3738 8807 alternatively email: elizabethpontes@hydrogengroup.com

The Hydrogen Group values confidentiality and will not share your details without your informed consent.

Apply for this job: Associate Director Regulatory Affairs

Contact Information:

Address:  Head Office
30 Eastcheap London
EC3M 1HD
England
Tel:  +44 (0) 207 002 0000

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