Regulatory Affairs Specialist

Proclinical

📍 Berkshire, England, United Kingdom

Contract Business Operations Specialists

Job Description

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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