Specialists in Pharma, Clinical & IT Recruitment

Regulatory Affairs Manager

Reference:
RAMUK
Job Type(s):
Regulatory Affairs
Salary:
Salary negotiable
Benefits:
Excellent Benefits
Town/City:
Berkshire
Contract Type:
Permanent
Date Posted:
08/01/2014 11:59:00

Description

My Client an expanding Pharmaceutical company has opened a new vacancy within their Regulatory Affairs team. They are actively looking to recruit a Regulatory Affairs Manager to their team on a permanent basis, for their offices in Berkshire.

The Role:

Obtaining and maintaining marketing authorisation/clinical trial applications in the EU (with specific reference to the UK/Ireland;   but also other territories as required e.g.  Australia).   To manage and develop the associated activities to maintain these licenses/authorisations, this may be through 3rd party vendors or in- house. To ensure that they comply with its obligations and responsibilities as an IND/MA holder/distributor.

Key Responsibilities:

  • Submission and approval of Clinical Trial Applications/ Marketing Authorisations in line with the company’s goals and objectives.
  • To   maintain   the   Marketing   Authorisations    of   the   company's    products   as appropriate.
  • Ensuring that renewal applications/PSURs and variations are prepared, submitted and processed in the correct time scale.
  • Ensure any commitments   made to or requests for additional information from regulatory   authorities   are   communicated   to   the   relevant   internal   personnel, especially that safety related issues are communicated to GDSP.
  • Ensure that 3rd parties meet agreed time lines.
  • Ensure that knowledge of regulatory affairs system and procedures is current.
  • Ensure that any changes to the Marketing Authorisations are communicated to the relevant internal personnel, especially that safety related issues are communicated to GDSP.
  • To ensure that the correct fees are paid to the regulatory Authority.
  • To comply with Health & Safety policies in order to safeguard the health and safety of self and others. 

Skills/Experience Required:

  • BSc/BA Degree in related discipline and/or equivalent experience
  • 3-5 years experience in regulatory affairs with demonstrated track record of achievement.
  • Knowledge and experience of EU and International Regulatory Legislation
  • Experience of MRP/DCP and National procedures
  • Experience of submitting quality and Safety variations

 

·         For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070

 

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