Specialists in Pharma, Clinical & IT Recruitment

Regulatory Freelancer

Reference:
RB07
Job Type(s):
Regulatory Affairs
Salary:
Salary negotiable
Town/City:
Netherlands
Contract Type:
Contract
Date Posted:
20/12/2012 12:40:00
Start Date:
20/12/2012
End Date:
31/03/2013

Description

The Company

My client, based in the Netherland are currently recruiting for a Regulatory Professional on a Freelance basis in the therapeutic area Immunology. The client's product portfolio focus in the areas of rheumatology, gastroenterology, dermatology and pulmonology. 

The Role 

  • Input in development, post approval and Life cycle management 
  • Liaison with Regulatory Agencies and Local Operating Companies
  • Act as backup for contact with Regulatory Agencies as needed
  • Assist in the preparation of meetings with Regulatory Agencies
  • Liaise with LOCs, track and respond to queries in a timely manne
  • Support of Marketing Authorization Applications (MAA) in EMEA region:
  • Provide regulatory support throughout lifecycle management
  • Clinical Trial Applications (CTA)
  • Advise team on required documents and submission strategies in preparation of CTAs
  • Ensure CTA submission packages are complete and available according to agreed timelines
  • Review and approve clinical trial supply plans

 
The Requirements

  • University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;
  • 4-8 years of relevant experience
  • Experience in MAA, CTAs and Lifecycle management is desired. 
  • Knowledge of the regulatory environment, guidelines and practice of EMEA regions
  • Team work experience.
  • Project Management
  • Oral & Written communication skills
  • Fluency in English
  • Organisation and multi-tasking

If you or anyone you know might be interested in this role- please do not hesitate to contact Reesa Berry on +441483 397070 or send an email to reesa@arc-7.com

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