Regulatory Affairs Manager - Emerging Markets

£0.00 - £70.00 per hour
  1. Permanent
  2. Project Manager, CMC
  3. United Kingdom
London
Posting date: 10 May 2019
23209_1557493904

A full-service global contract research organisation (CRO) is seeking to recruit a Regulatory Affairs Manager - Emerging Markets. The company provides a broad range of product development and data solution services to pharmaceutical and biotechnology companies around the world and has participated in more than 3,800 clinical trials. Joining this CRO in London, the RA Manager will provide strong clinical and non-clinical understanding and expertise. The vacancy offers an exciting opportunity to provide experience and bolster a career in the regulatory field.

Job Responsibilities:

  • Handling global Regulatory Affairs maintenance work on licensed product(s) in close collaboration with regulatory counterparts in affiliate companies
  • Planning, managing, and executing regulatory activities on licensed product(s), such as submission of variations, renewals, line extensions, responses to Authority requests, and Marketing Authorisation Applications in further countries.
  • Providing functional input to the global regulatory team and other internal teams.
  • Planning, managing, and executing regulatory activities on product(s), such as submission of variations, renewals, line extensions, responses to request for further information, Marketing Authorisation Applications in further countries.
  • Driving submissions through the approval procedure (MRP, DCP, CP) in Emerging Markets.
  • Interfacing with regulatory counterparts in affiliate companies to support regulatory activities on assigned product(s).
  • Providing functional input to the global regulatory team and other internal teams.
  • Successfully interacting with the project and functional teams to ensure that data generated is appropriate and will be compiled and submitted in accordance with Emerging Market requirements.
  • Directly communicating with Regulatory Authorities to facilitate productive dialogue on assigned product(s).
  • Liaising with external companies with respect out-licensing supporting activities as required.
  • Reviewing and coordinating PSUR submissions.
  • Handling of regulatory documents in the electronic document management system.
  • Handling of product-related information in the registration database.
  • Complying with all applicable regulatory requirements and company standards and procedures.

Skills and Requirements:

  • Experience in global Regulatory Affairs maintenance work.
  • Experience in submission of new marketing authorisation applications.
  • A degree in pharmacy/life science or similar.
  • Additional Regulatory professional qualifications is an advantage.
  • Proven Emerging Markets regulatory submissions capability, in particular in post authorisation activities (minimum of 5 years of experience).
  • Experience in interactions with Emerging Markets in relation to all aspects of regulatory activities.
  • Experience working with CROs and/or contractors.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.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.

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