Senior Regulatory Affairs Associate

Location
England, London / England / England, Cambridge, Cambridgeshire
Salary
£27 - £32 per hour
Posted
15 Jul 2019
Closes
29 Jul 2019
Ref
BT489
Contact
Billy Twomey
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

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 /

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