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Regulatry Compliance Specialist

Posted 23 February by Apodi Easy Apply Ended

Our client, a global pharmaceutical business is recruiting for a Regulatory Compliance Specialist to join their busy team in Basingstoke.

Your role as a Regulatory Compliance Specialist will be to manage the regulatory requirements from teams in Northern Europe with emphasis on the UK/IE. You will be accountable for managing the communication and reporting of competent authorities.

Your duties as a Regulatory Compliance Specislist will include but not limited to:

  • Responsible for adverse events reporting to the local competent authorities in a timely manner in UK and Ireland
  • Responsible for reviewing and coordination of answers to requests of information; including the monitoring of all the requests on company system. Report on issues.
  • Responsible for taking PRE-local decisions in case of incidents and to report these on the company system.
  • Communication to customers, third parties and Internal support for other employees regarding regulatory compliance as needed.
  • Accountable for reaching the reconciliation of the implemented Field Safety corrective actions
  • in NEC and communicating regularly with the CA.
  • Assist in any duty within the company as is reasonably requested

You will have previously worked in a similar role with 3-5 years of experience, and will ideally have a Scientific/Biology/Microbiology degree. You will have managed competent authorities, have previously managed or arranged audits, and will have experience in regulatory affairs and compliance.

A competitive salary and benefits are on offer. If you are looking for a new challenge, then please do apply!

Reference: 34541131

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