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Senior Regulatory Affairs Associate

  1. England, London
Remote work
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
36503
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Senior Regulatory Affairs Associate – Contract – Pharmaceuticals

Do you relish the opportunity to work with an international pharmaceutical organisation based in the UK?  If yes, then this is the assignment for you!

Our client that specialises in delivering medicines for patients with swallowing difficulties, across a range of therapeutic areas

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Independently execute variations for existing marketing authorisations to be submitted as per the relevant competent authorities’ requirements and in compliance to local laws and regulations. Including the compilation of responses to authority questions within agreed timescales. Related to sustain/maintenance projects: Active participation as regulatory affairs representative in meetings with internal & external stakeholders, working cross functionally to achieve the business goal. As a product owner, providing comprehensive regulatory advice to support the business including change control SME.
  • Develop and approve product information text in compliance with SOPs and relevant guidelines for variations.
  • Maintenance of regulatory systems and provide timely notification to internal & external stakeholders in line with KPIs to ensure compliance to the marketing authorisation.
  • Develop and approved product information text in compliance with SOPs and relevant guidelines for variations.
  • Support associate team members.
Desirable Experience:
  • Current awareness of legal framework and forthcoming legislation that may affect the business
  • Understanding of the workings of global competent authorities.
  • Good understanding of variations in UK and EU. Knowledge globally would be beneficial.
  • Good CMC knowledge; eCTD beneficial
  • Shows initiative and drive, particular when faced with a problem
  • Demonstrates good planning abilities with flexibility and agility
  • Excellent written and verbal communication skills essential, including good attention to detail
  • MS-Office knowledge essential
If this role is of interest to you, please apply now!

 #LI-KT1


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