Deputy Compliance Manager

2 weeks ago

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

We are seeking a highly skilled Deputy Compliance Manager to join our Regulatory Affairs team at Select Pharma Limited. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our marketing authorisation submissions.

Key Responsibilities
  • Document Management: Collect, organise, and track documentation required for marketing authorisation applications and respond to questions in eCTD format.
  • Document Review: Check documents for accuracy, consistency, deficiencies, and compliance with regulatory submission requirements.
  • Submission Preparation: Compile module 1-5 CTD registration packages for new marketing authorisation submissions.
  • Submission Management: Submit necessary applications through electronic gateways.
  • Regulatory Communication: Respond to regulatory information requests.
  • Team Collaboration: Assist our business in delivering quality regulatory submissions to agreed project targets.
  • Process Review: Participate in the review of process/product changes and batch recall to determine the need for any regulatory activities and to ensure compliance with regulatory requirements.
  • Procedure Development: Assist the Department Head in developing procedures to ensure regulatory compliance.
  • Knowledge Management: Familiar with work instructions, practices, and procedures of the Company.
  • Communication: Communicate with product development teams and organise meetings for tracking project status and timelines.
Requirements
  • Regulatory Knowledge: Knowledgeable in CTD compilation.
  • Submission Requirements: Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for EU submission types.
  • Technical Skills: Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
  • Personal Skills: Ability to work independently with minimal supervision as well as work in a team environment with changing timelines and priorities.
Working Conditions
  • Job Type: Full-time
  • Pay: £45,000.00-£50,000.00 per year
  • Additional Pay: Bonus scheme
  • Benefits: Company pension, Free parking, On-site parking
  • Schedule: Monday to Friday
  • Work Location: In person

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