Regulatory Affairs Specialist

1 month ago


Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Job Description

Deputy Regulatory Affairs Manager

At Select Pharma Limited, we are seeking a highly skilled Deputy Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth submission of marketing authorisation applications.

Key Responsibilities:

  • Collect, organise, and track documentation required for marketing authorisation applications and respond to questions in eCTD format.
  • Verify documents for accuracy, consistency, deficiencies, and compliance with regulatory submission requirements.
  • Compile module 1-5 CTD registration packages for new marketing authorisation applications.

Requirements:

  • Strong knowledge of regulatory affairs and compliance.
  • Excellent communication and organisational skills.
  • Ability to work in a fast-paced environment and meet deadlines.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

How to Apply:

Please submit your application, including your resume and a cover letter, to [insert contact information].



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