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Regulatory Affairs Associate

Job title: Regulatory Affairs Associate
Contract Type: Contract
Location: Hampshire, England
Industry:
Salary: Competitive
Reference: BH-91906
Contact Name: Syeda Islam
Phone Number: 0161 942 4000
Job Published: 24 days ago

Job Description

Regulatory Affairs Associate – Hampshire – Contract

The licensing of a drug new or existing is a regimented process which is varied according to geographical locations. Various factors are required to be taken into consideration to ensure the correct licences can be obtained allowing the public access to such therapeutics to enhance overall quality of life. To maintain this critical element of the product life cycle a position has become available with a leading pharmaceutical company. My client is a market leader within the pharmaceutical industry with presence in over 125 countries. The details of this position within the regulatory department includes -

Regulatory Affairs Associate Key Responsibilities:
  • Be responsible for all tasks associated with product licencing for the purpose of marketing
  • Ensure all submissions are submitted with the relevant regulatory body
  • Provide regulatory insight and support all clinical trials activity which includes safety reports, labelling and amendments
  • Ensure all activity regarding clinical trials and regulatory licensing is recorded using appropriate systems
  • Be responsible for translation and coordination of all documents for the region responsible
  • Support and provide solution to all regulatory disputes
  • Be key point of contact to with the regulatory agencies and internal members of the team
  • Provide guidance to relevant personnel’s to ensure and facilitate timely submissions  of applications, marketing content and labelling materials
  • Be aware of and have full understanding of regulatory processes according to the regional legislation and ICH guidelines
Regulatory Affairs Associate Key Requirements:
  • Minimum degree qualification in a relevant life sciences subject
  • Very good understanding of product life cycle
  • Previous experience handling regulatory procedures within an UK & EU market
  • Deep technical understanding of requirements necessary to secure product licence
  • Understanding of global regulatory process and being aware of all proposed changes that can affect the product responsible
  • Very good written and spoken communication skills
  • Good interpersonal skills in order to maintain good relationship with all teams responsible domestically and internationally
  • Able to make decisions to positively impact all aspects of the regulatory process
  • Be highly organised and ensure all deadlines are met while maintain high quality at all times
This is a contract role and to be considered candidates must be eligible to work in the UK. If successful you can expect a competitive salary package as well as the opportunity to join a world leader in global pharma.

Please contact Syeda Afsana Islam on 0161 942 4060 for more information on rates and applying.

Regulatory Affairs Associate – Hampshire – Contract

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