Posted to MedZilla on 8/19/2017


ProClinical

England, Regulatory Consultant RA_NS_13086-MZ


 
 

Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Regulatory Affairs Consultant to join a global top 10 pharmaceutical company at their offices located in Tadworth, Surrey. The role of the RA consultant is to allow the company to legally study, manufacture, market and supply medicines. To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements.

Job Responsibilities:

  • Contribute to Cross-functional Teams and Build Regulatory Expertise.
  • In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
  • Represent Regulatory Affairs on product based teams.
  • Provide regulatory input to commercial strategic and operating planning process.
  • Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
  • Build personal expertise through management of specified products within one or more therapy areas.
  • Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
  • Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
  • Work with PEH RA regional strategists to provide country input into Global and European Regulatory Strategies as required.
  • Seek to improve alignment of local and regional regulatory strategy and tactics.
  • Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
  • Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional company colleagues and direct or indirect interactions with external customers.
  • Advise on matters of compliance, regulatory requirements and company regulatory policy.
  • Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.
  • Manage and Submit Marketing Authorisation Applications:
  • National/MRP/Decentralised MAA:
  • Partner with above-country operational hubs and PEH RA strategists to review, co-ordinate and, where required, create necessary technical data to support country submissions e.g. provide national specific module 1 data. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.
  • Centralised MAA
  • Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.

Skills and Requirements:

  • Computer literacy
  • Excellent written and verbal communication skills
  • Proven strength in analytical thinking
  • Qualifications (i.e., preferred education, experience, attributes)
  • Life sciences or chemistry graduate to honours level or equivalent
  • Masters Degree, Post Graduate Diploma or PhD preferred
  • Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
  • Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
  • Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred

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 call Numhom Sudsok on +44 203 8718 093 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.


Please visit our website at www.proclinical.com

 
 


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