Regulatory Affairs Project Manager

  • Salary: Competitive
  • REF Number: 00031437
  • Consultant: Oliver Care
  • Contact: 01438 842976
  • Date Published: 28.11.2014
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Oliver Care is recruiting for Regulatory Affairs project Manager to join a company in the pharmaceutical industry at their site based in Berkshire on a permanent basis.

The main purpose of the role will be to

  • Prepare, submit, coordinate and maintain national MAAs for a portfolio in accordance with local and EU requirements and finalise the national phase of MAAs submitted via MR or DC procedures.
  • Liaise with commercial teams and communicate key regulatory issues that may affect product development or product launches and keep up to date with current and new legislation/guidance to ensure that work is compliant with the statutory requirements.
  • Develop and maintain regulatory SOPs as required.

Further responsibilities will include:

  • Compile and submit CMC variations, labelling variations and renewals in line with SOPs and authority requirements and monitor timelines for generating/submitting renewal documentation on a monthly basis.
  • Ensure submissions are made in agreed timelines and in line with department schedules/priorities and compile the regulatory documents in eCTD or Nees format.
  • Maintain the company's Manufacturer's/Importer's Authorisations and Wholesale Dealers Licenses and submit Notification of Intention to Import applications.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or above in a life sciences or related field with extensive Regulatory Affairs Experience of handling complex licenses in terms of full submissions and maintenance.
  • Experience of dealing with Health Authorities
  • Organised with a hands on attitude and good communication and decision making skills.

This is an excellent opportunity to join an exciting neurology specialist pharmaceutical company with an interesting product portfolio.

For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31437 in all correspondence.

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