Senior Regulatory Affairs Associate

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 /