Regulatory Affairs Officer - West Sussex, United Kingdom - Hyper Recruitment Solutions Ltd

Hyper Recruitment Solutions Ltd
Hyper Recruitment Solutions Ltd
Verified Company
West Sussex, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

We are currently looking for a Regulatory Affairs Officer to join a leading Pharmaceutical company based in the West Sussex area.


KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:

  • Make sure all regulatory submissions for medicinal products for European and Non-European countries are in line the local requirements and regulations.
  • Prepare quality CMC documentation for regulatory submissions, for example; MAAs, responses of deficiencies, variations and ICH requirements.
  • Provide different teams internally regulatory guidance and advice. This will include training more junior team members.
  • Comply with all legislative requirements, good manufacturing practices, quality management systems and site regulations.

ROLE REQUIREMENTS:

  • Relevant degree in a scientific degree.
  • Proven industry experience in a regulatory pharmaceutical field.
  • A working knowledge and practical experience with current CMC regulatory requirements.

Key Words:
RA, Regulatory Affairs, Pharma, GMP, CMC, ICH
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