Senior Regulatory Affairs Associate - III

Location
England, Cambridgeshire, Cambridge / Uxbridge, England, London / England
Salary
£27 - £32 per hour
Posted
09 Jul 2019
Closes
23 Jul 2019
Ref
BT486
Contact
Billy Twomey
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Senior Management

Job Title

Senior Regulatory Affairs Associate

Pay Rate:

£27.00-£32.00 Per Hour

Location:

Cambridge or Uxbridge

Main Responsibilities:

  • Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
  • Preparation and/or coordination of regulatory labelling variation submissions for the company's marketed products in line with corporate objectives.
  • Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review and provision of accurate labelling translations.
  • Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.
  • Represent International Regulatory Affairs (Int RA) function at cross functional submission/ study management team meetings.
  • Participate in regulatory HIV team meetings, product team meetings and departmental meetings.
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  • Support the HIV Int RA team as required.

Candidate Key Skills:

  • Able to facilitate/impact and influence effective interactions and discussions
  • Able to effectively interact to information gather and effectively drive projects through to completion to tight timelines.
  • A good scientific background and understanding

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)2031890460 or +31 (0) 208081504 or email at btwomey@i-pharmconsulting.com. If this role is not suitable, Billy is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
Quality Assurance / QA / Quality Assurance Specialist / Biopharmaceutical / Dun Laoghaire / Contract / Pharmaceuticals / Pharma / Ireland /