Looking for a new career opportunity?
Invenia Group has partnered with a fast-growing pharma company, looking to hire a Principal Regulatory Officer for its team of experts, based in the UK.
Role responsibilities:
You will ensure timely and effective regulatory submissions are made to support the objectives of the New Product Delivery (NPD) team, contribute to and support team and company objectives in line with regulatory and other relevant requirements as well as internal and external standards, and provide CMC regulatory expertise across product development, due diligence and reviewing documentation to ensure accuracy and high quality. You will also:
- Be 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 the line manager
- Ensure regulatory submissions are made on time and any delays are communicated to all relevant stakeholders promptly to minimise impact to the business
- Takes responsibility for proactively managing complex issues with regulatory authorities, third parties and internal colleagues to ensure swift approvals of regulatory applications. Interacts directly with regulatory authorities on defined matters, liaises with, and makes presentations to regulatory authorities on defined matters, including negotiating regarding marketing authorisations
- Provide regulatory input on pharmaceutical development and CMC, and review quality documentation to ensure regulatory compliance with UK and EU legislation
- Perform Due Diligence on dossiers under development and ready for in-licensing
Qualifications, Experience & Knowledge Required:
- 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 in 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
Sound interesting? Apply to find out more.
