Senior Regulatory Associate, Global Regulatory Affairs

CK Group is recruiting for a Senior Regulatory Associate, Global Regulatory Affairs to join Global Pharmaceutical company. Flexible working from home is available.

Senior Regulatory Associate Role:

• To focus on regulatory operational supportfor all stages of regulatory submissions including planning, compilation, production, submission, response to questions and approval
• Timely entry of regulatory activities into regulatory tracking systems, and the electronic trial master file (eTMF).
• To support the clinical development process for key compounds assigned by ensuring the timely submission of Clinical Trial Authorisation (CTA) applications and providing advice on EU regulatory clinical trial requirements to the InternationalProject Teams (IPTs) or Regulatory Sub-team.
• To provide support to regulatory leads with regulatory submission preparations to regulatory agencies.

Your Background:

• Degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology) or equivalent.
• Demonstrated experience with regulatory operational support, for example regulatory tracking systems and eTMF
• Familiarity with EU clinical trial regulatory processes
• Excellent written and verbal communication skills
• Strong problem-solving skills and eye for detail

Apply:

Entitlement to work in the UK is essential. For more information or to apply for this Senior Regulatory Associate position, please contact Chloe Merrill on01438 870 022 or email cmerrill@ckgroup.co.uk. Please quote reference 52237.to USPI's, CRP SmPCs and MRP/DCP-SmPCs as necessary.

Your Background: As Manager Global Labelling, you will require:

• A relevant Life Science degree.
• Proven experience creating and maintaining CCDS or/and SmPC and/or UPSI
• Demonstratedexperience in Regulatory, R&D or relevant experience within pharmaceutical industry, with solid experience in labelling
• Experience of European regulatory procedures (Centralized, MRP and DCP
• Proven interpersonal skills, negotiating, communicating, coaching, and explaining.

Apply: For more information or to apply for this Manager Global Labelling position, please contact Ashleigh Williamson on 01438 842 978 or email awilliamson@ckgroup.co.uk, quoting job ref 52238.

It is essential that applicants hold entitlement to work in the UK.nce 52288.

CLINGENutcomes, retrospective and prospective data analyses, registry, epidemiology or health services research

• Expert insight and knowledge in Health economics and model development
• Skilled in translating complex economic concepts into simple language.
• Good understanding of current UK health care system and market access issues
• Demonstrated experience of project management
• Strong numeric skills
• Scientific/medical knowledge
• A commercial mindset

Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.