Regulatory Affairs Manager / Senior Manager

About

Scienta are proud to be partnered with a small, commercial stage pharmaceutical company focusing on small molecule protease inhibitor products in their search for a Senior Manager of Regulatory Affairs.

Role

The role will be focused on regulatory drug development activities, from early stage to MAA in the EU, UK and US, and the supporting regulatory strategy.

Responsibilities:

• Preparation of initial IND/CTA submissions and maintenance through to study completion, including oversight of external CROs where appropriate
• Prepare and/or review clinical trial associated documentation (including IMPDs, IBs, protocols and labelling)
• Ensure regulatory systems, such as regulatory databases/trackers, are implemented and kept up to date.
• Provide support, where required, in the preparation for Regulatory Agency meetings (e.g. scientific advice).
• Preparation of other regulatory documentation (e.g. DSURs, PIPs/PSPs, Orphan Drug Designation applications, Fast Track applications etc).
• Provide support for regulatory strategy and development in other ROW regions
• Provide input to regulatory strategies for development products
• Build good relationships with competent authority personnel
• Maintain compliance with the Quality System and work to industry standards of GxP
• Maintain current knowledge of relevant legislation in the UK, EU, US and all appropriate guidelines (including ICH).
• Provide input into regulatory intelligence and work with other functions to implement any changes in legislation or guidance

Experience

• A degree or equivalent in a Life Science subject.
• 4-7 years of regulatory experience with a good knowledge of early phase drug development/translational science
• Demonstrated ability to manage priorities and to work autonomously to tight timelines.
• Demonstrated ability to work with cross functional teams.
• Strong medical or technical writing skills and attention to detail essential.
• Excellent interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
• Proficient with Microsoft Office products.

Why Apply?

This is a fantastic opportunity to be heavily involved in the development of new drug products at a small, innovative pharmaceutical company.