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Job Details

Senior Regulatory Manager - UK and Ireland

Company: ProClinical Ltd
Location: Cambridge
Reference: RA.PD.9976
Closing Date: 06 Dec 16
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

ProClinical have a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Senior Regulatory Manager to join their team at their offices in Cambridge, UK. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation. ...

Requirements:

ProClinical have a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Senior Regulatory Manager to join their team at their offices in Cambridge, UK. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation. 

Job Responsibilities include, but not limited to:

  • Maintain awareness of the current priorities and regulatory needs of the UK and Ireland IAC.
  • Plan, coordinate and prepare MA Applications for submission via National procedures.
  • Provide advice and prepare local documentation for MA Applications for submission via European procedures.
  • Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.
  • Management and submission of all national phase activities following the completion of DCP/MRP procedures.
  • Manage the UK and IE Artworks through the Bard Artwork Management System (BART)
  • Manage the maintenance of SmPC and PIL texts on the local websites (eMC/ Ipha)
  • Keep the local companies informed of changes to the product information to allow them to fulfil their business needs effectively.

To Apply:

If you would like to find out more about the requirements for this vacancy, please click the Apply button.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV to p.duvall@proclinical.com
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Senior Regulatory Manager - UK and Ireland

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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