Senior Regulatory Affairs Associate - III
- Experience Level
- Senior Management
Senior Regulatory Affairs Associate
£27.00-£32.00 Per Hour
Cambridge or Uxbridge
- 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.
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 email@example.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.
Quality Assurance / QA / Quality Assurance Specialist / Biopharmaceutical / Dun Laoghaire / Contract / Pharmaceuticals / Pharma / Ireland /