Regulatory Senior Specialist:Global Organisation

Job type:
Real Staffing
City of London
flag_no United Kingdom

Project description:
This project is archived and not active any more.
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Regulatory Affairs Senior Specialist: Global Organisation

Salary: Up to £60,000 + paid overtime and Excellent package

I am currently working for a global organisation who are building a new Regulatory Affairs team. There is currently 2 positions available at this level and few roles a the level down (Regulatory Specialist).

The Regulatory director is interested in candidates that have a broad Regulatory background who have strong communication and business acumen skills.

Key Responsibilities Include:
  • Conduct regulatory reviews of technical summaries, quality, nonclinical and clinical study reports, and administrative documents for regulatory filings.
  • Assist with the filings and approval processes for MAA products within all types of European Regulatory Procedures. Also with MAAs outside of the EU Member States including and not limited toSwitzerland,AustraliaandSouth Africa
  • Assist with the assembly of Common Technical Document (CTD) and electronic CTD filings
  • Assist with providing regulatory expertise on of MA life cycle management (variations, renewals, labeling, and line extensions
  • Provide mentoring support to publishing associates and specialists.
  • Assure submissions adhere to EU and ICH guidelines and working knowledge of key health authorities in the EU including the EMA,GermanyandUK
  • Interact with clients regarding regulatory issues.
  • Interact with other European Team Members in supporting the growth of the European Organisation

If you are keen to find out more information on this role or any other Regulatory Opportunities in the UK contact Natalie Hopkins at n.hopkins(a) or call

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