Principal Regulatory Affairs Officer

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 expectations for CMC compliance.
• Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
• In depth knowledge of UK and European regulatory affairs legislation and guidance.
• Planning and organisation skills - Ability to handle multiple tasks/projects and manage priorities accordingly.
• Able to work under pressure and to strict deadlines.
• A confident credible communicator with good negotiation skills.
• Able to build relationships at all levels of the business.
• Excellent written communication skills with attention to detail.
• Able to independently identify and initiate tasks/projects.