Principal Regulatory Affairs Officer in City of London

Responsibilities

• Responsible for the provision of full regulatory input and support for assigned products across the submission and assessment phase which includes the preparation, submission and response to questions for new Marketing Authorisation Applications. Manages increasingly complex submissions making decisions independently and with minimal referral to line manager.
• Ensure regulatory submissions are made on time and any delays are communicated to all relevant stakeholders in a timely manner so as to minimize impact to the business
• Provide regulatory input on pharmaceutical development and CMC and review quality documentation to ensure regulatory compliance with UK and EU legislation
• Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.

Qualifications and Required Experience

• Degree in a suitable scientific discipline (biological / chemistry / life sciences).
• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• Solid understanding of pharmaceutical manufacturing processes, analytical methods and regulatory expectatio…