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Job Details

Associate Director - Global Regulatory Affairs

Company: ProClinical Ltd
Location: Berkshire
Reference: RA.PD.10455
Closing Date: 26 Jan 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

An internationally known biotechnology company has an opening for a Associate Director job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. Job Role: Responsible for developing and implementing innovative European regulatory strategies for product under development, through application to approval. ...

Requirements:

An internationally known biotechnology company has an opening for a Associate Director job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. 

Job Role:

  • Responsible for developing and implementing innovative European regulatory strategies for product under development, through application to approval. 
  • Represent the company with regulatory authorities, contractors and corporate partners. 
  • Represent the international regulatory function cross functionally, within the asset team, and within company teams/committees. 
  • May manage direct reports. 
  • Provide mentoring and support to colleagues in the department

Job Responsiblities:

  • Responsible for defining and implementing regional regulatory strategies (primarily EU), including filing of regulatory submissions for assigned programs
  • Secure alignment across function and with partners
  • Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
  • Define and ensure execution of regional labelling strategy, taking global labelling strategy into consideration
  • Provide regulatory guidance to company personnel throughout the research and development process.
  • Direct the preparation of clear and effective submissions.
  • Prepare and deliver effective presentations for external and internal audience.
  • Monitor and analyse appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
  • Provide input to regulatory senior management teams as required.

Qualifications and Experience:

  • BA/BS/University degree required, Life/Health Sciences preferred
  • Minimum of 5 years Regulatory experience
  • 10 years pharmaceutical/biotechnology industry experience
  • Experience of leading major regulatory submissions (MAAs), Line extensions,
  • New Indications (preferably via the Centralised procedure), leading agency scientific advice meetings
  • Solid knowledge of applicable regulations
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Direct experience in interfacing with relevant regulatory authorities.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies

Apply for this job: Associate Director - Global Regulatory Affairs

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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