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Job Details

Senior Director of Global Regulatory Affairs Strategy

Company: Chiltern
Location: Any Europe
Reference: HK-SDGR1
Closing Date: 21 Jul 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Senior Director of Global Regulatory Affairs Strategy required for market leading Global CRO. This role can be based in various European locations.

Requirements:

Job Background

Covance, a leading global CRO, have an exciting opporiutnity for Senior Director of Global Regulatory Affairs Strategy (GRAS).

 

The Senior Director of Global Regulatory Affairs Strategy (GRAS) will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives. This responsibility will include leading client interactions with Regulatory Agencies globally. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactical plans to meet their drug development needs globally.

 

Collaborate closely with internal Covance project teams in the design and development of regulatory strategies for client projects or to answer client inquiries.

  • Collaborate with the rest of the GRAS group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise.

  • Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by EMA, FDA, Health Canada, and elsewhere.

  • Interact and collaborate with all Covance business unit personnel

  • Establish productive working relationship and collaborate closely with Regulatory Submissions staff.

  • Create and build confidence by representing the regulatory strategy function as an informed, capable, knowledgeable, responsible and accessible resource to Covance staff, management and clients, positioning Covance as a preferred source for regulatory strategy expertise.

  • Build successful working relationships with business and scientific leaders across Covance. 

  • Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.

Requirements:

  • Extensive experience of  drug development in the Pharma, biotech or CRO industry with a significant amount of  experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.
  • Good expexperience working with Regulatory agencies at a Global level
  • CNS expertise
  • Lab expertise
  • Experience working with FDA is desireable
  • Strong leadership skills essential
  • An advanced degree with a focus in the sciences is required.

Salary

Competitive

Position Type

Permanent
Full Time

Contact

Email Hannah King - Hannah.King@chiltern.com
+44 (0) 1753 216639

Apply for this job: Senior Director of Global Regulatory Affairs Strategy

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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