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Senior Regulatory and Compliance Specialist – 12 months FTC

map_markerUxbridge Coin£20 to £22

Vacancy summary

Vacancy summary

Reference: 07603

Job Type: Contract

Date Posted: 12 February 2019

  • Working for a global pharmaceutical company
  • Excellent opportunity to work for a company that truly value their employees
  • Joining a fast paced, proactive team

Senior Regulatory and Compliance Specialist – 12 months FTC

A Global Pharmaceutical company based in Uxbridge is currently looking to recruit a Senior Regulatory and Compliance Specialist to join their team. We are seeking a talented individual who is ready to hit the ground running on a 12-month contract and would thrive in joining this fast-paced department. 

Responsibilities include:

  • Providing support on UK / Ireland regulatory activities and collaborating closely with international (European / EU) offices for EU regulatory matters
  • Executing the UK regulatory submission strategy in partnership with the Senior Regulatory Affairs Manager
  • Keeping abreast of legislative changes, guidelines, national and EU regulatory data to ensure compliance and best practice is always followed through
  • Acting as a Privacy Lead (GDPR)
  • Making sure all departments are aware of the changes regarding product information
  • Working closely with Drug Safety department and supporting them with regulatory knowledge
  • Tracking and identifying the missing or incorrect information in terms of Clinical Trial Applications (CTA)
  • Optimising CTA’s through pre-submission review process
  • Making sure that all products are marketed in a fully complaint manner with marketing authorisation
  • Supporting the Market Access and Corporate Affairs with clinical and regulatory documents
  • Managing the pricing and reimbursement dossier as requested
  • Generating periodic reports and conducting audits 

Skills and knowledge:

  • A scientific degree (Batchelors or equivalent and above)
  • Previous experience in Regulatory Affairs and Compliance within pharmaceutical industry
  • Ability to multitask and prioritise work flow
  • Excellent communication and time management skills
  • Strong attention to detail
  • Ability to work within the team with leadership attitude

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

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