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Job Details

*** OPTION SUISSE *** Int'l Regulatory Project Manager *** Want to lead high profile reg dvlpt of pivotal trials and MAAs for BRICKM?

Company: Advanced Regulatory (EU Roles)
Location:
Reference: MGADV25022012/D
Closing Date: 01 Sep 14
Type: Full Time
Salary (£): On Application
Benefits: On application

Job Summary:

Please consider this role! To respond, for French and German speaking candidates should apply to Marc Van de Voorde in our Swiss office, Marc@Advregulatory.com or on +41 (0)78 170 4042 and for candidates from the UK, NL and rest of world to Matt Greig, in the UK London office, to Matt@Advregulatory.com or call +44 (0)7918 679 405.

Requirements:

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*** OPTION SUISSE *** International Regulatory Project Manager *** Want to lead high profile regulatory development of pivotal trials and MAAs in the major BRICKM countries? 4-6 years in RA RoW? Great lifestyle and projects await you!

Expansion of marketed products in the most of world area is a great objective, but my client wants to go further and has been changing the way Most of World and RA in the EU and US works together to ensure parallel development in all major markets in their Phase 3 trial programmes. You will hold this torch in this role.

You will be an experienced international RA regulatory development programme manager with existing capabilities in defining RA strategy for the regions and working with local affiliates to define the regulatory pathway, ensuring correct negotiation with national Regulatory Authorities for trials, submissions and the first round of line extentions.

This is a regulatory development role in the same sense as an EU or US position with a focus on the important other markets. Big brands are developed and managed in this regulatory organisation!

You will have experiences in leading MAA submissions for all modules (this is not a CMC role) and be experienced in negotiating with country HAs in a specific region, whether this is across all E7 or for any of the following: Asia Pac, India and SubContinent, Russia and CIS, ME and Africa and LatAm.

You will be able to and interested in working in Switzerland (my client provided support for relocation and residents / work permits). You will be able to speak English to an advanced level, although other languages are valued it is your regulatory procedure and development experiences my client will be most interested in, and your ability to take responsibility and project manage regulatory activities across concurrently across many regions.

Of course, Switzerland and my client offer a life changing opportunity; Advanced will provide you with the support necessary as an orientation and during the interview process for this established and expanding global leader!

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About Advanced

Advanced Regulatory in the UK and Advanced Search and Selection in Switzerland are leading European recruiters for Regulatory Affairs, Quality, Medical and Market Access. Please see our web site for other positions in these areas www.advregulatory.com

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
1 Calico House
Clove Hitch Quay
Plantation Wharf
Battersea
London
SW11 3TN
England
Tel:  +44 (0)207 801 3380
Website:  Visit Our Web Site

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