Regulatory Affairs Manager
This position will be responsible for ensuring efficient and productive regulatory submissions for UK/I, as well as assisting and collaborating in strategic drug development program implementation for Europe. This individual will provide support for the preparation of UK/I and EU regulatory submissions including but not limited to CTAs and MAAs as well as other pre- a/o post-authorization interactions with regional and local regulators).
Key Duties will include:
· Support regulatory strategies for assigned projects that will result in the on-time submission and approval of new products, indications, and variations and ensure proper maintenance of existing product applications.
· Working with Regulatory Operations, compile, prepare and submit meeting requests and packages, CTA, MAA, and other required UK/I as well as EU regulatory filings as necessary to implement the agreed upon strategy.
· Provide support to Project Teams for submissions to ex-US regulatory authorities.
· Interact with UK MHRA and IMB and possibly further European NCAs for the coordination and preparation of meetings and teleconferences and conduct informal interactions with the Agency’s personnel as directed by senior regulatory management.
· Review/revise/draft Standard Operational Procedures as required to assure compliance with European Health Authorities’ Regulations and Guidance Documents and in line with the company’s global and regional processes and procedures.
· Manage regulatory timelines ensuring that regulatory strategies are executed within those approved timelines. Communicate and manage risks around timelines during the project.
· Maintains currency with European regulations and guidance regarding CTAs, MMAs and electronic submission requirements. Is familiar with FDA regulations and guidance and others as appropriate.
· Provide Regulatory Intelligence support to the Project Teams, to include the monitoring, gathering and analysing of publicly available and experience based regulatory information to support optimization of drug development programs.
· Keep senior regulatory management advised on project related issues and timelines.
· Develop and maintain strategic relationship with key business partners (General Management, Medical, Market Access) to ensure optimal collaborative set up in the pre- and post-authorization space in UK/I and other European territories, as assigned
The successful candidate will have:
· Bachelor’s or Master’s degree, preferably in a scientific area
· 5 or more years’ experience in Regulatory Affairs in the Pharmaceutical Industry, ideally in an above-country, regional setting
· Hands-on experience with post-BREXIT UK regulatory activities
· Excellent written and verbal communication skills
· Excellent presentation skills
· Excellent negotiation skills, ability to maintain high ethical standards, possess ability to make decisions, and enjoy working in a team-oriented culture.
For more information please contact Clodagh D'Arcy on 01 9476356 or email details to firstname.lastname@example.org