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Regulatory Affairs Specialist

Company

Proclinical

Location

Berkshire, England

Type

Contract

Are you ready to shape EU and global regulatory strategies that bring innovative analgesics and anaesthetics to market?

Proclinical is seeking a Regulatory Affairs Specialist to join a dynamic team in UK. This role focuses on EU and global regulatory strategies within the pharmaceutical industry, particularly in analgesics and anaesthetics. You will play a key role in managing regulatory submissions, ensuring compliance with applicable regulations, and contributing to the development and lifecycle of pharmaceutical products.

Responsibilities:

  • Collaborate with EU and Global Regulatory Leads to define and implement regulatory strategies for assigned projects.
  • Oversee the preparation, submission, and management of regulatory filings, including CTAs, PIPs, scientific advice, MAAs, and variations.
  • Identify and assess regulatory risks, developing strategies to mitigate them effectively.
  • Support the development of EU product information an...
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