Ass Director /consultant -Regulatory Affairs - EU & EMEA

The Associate Director of Regulatory Affairs/ principle consultant is a key member of our client's executive leadership team. Our client is a leading service provider for the healthcare industry. The person in this role will lead all aspects of global project regulatory affairs for fast growing pharmaceutical companies across the globe.

You will identify the key strategic regulatory drivers for early and late stage programs for submissions (from IND to BLA) to US and international regulatory agencies. This position also will be responsible for developing, establishing and maintaining effective relationships with regulatory agencies, especially the FDA, overseeing all Regulatory Affairs activities.

* Regulatory strategy and contributing to development programmes.
* Regulatory intelligence.
* Assessment of scientific data and technical writing, including overviews and summaries.
* Preparation and management of regulatory submissions and procedures (e.g. for national or centralised scientific advice procedures, clinical trial authorisation applications, marketing authorisation applications, orphan designations, PRIME, post-authorisation procedures, PIPs, waivers and/or deferrals). Includes advising clients of best strategy and navigating clients through the processes in addition to hands-on activities required to prepare and submit documentation.
* Representation of clients with regulatory authorities including acting as the primary contact point and taking a leading role in interactions with regulatory agencies.
* Licensing and 'due diligence'.
* Supporting business development.

To be successful in this role you should have:
* Solid background in pharmaceutical or consultancy industry
* BSc/MS/PhD in Life/Health Sciences.
* A proven leader with 8+ years regulatory experience in regulatory role

Salary: Competitive

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 02079402105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.