Description
An excellent opportunity has arisen for a Senior Manager / Associate Director of International Regulatory Affairs to join a leading Pharmaceutical company based in Oxfordshire / Berkshire. Within this role you will be responsible for EU/ROW regulatory activities and direct the company's regulatory affairs activities and initiatives. You will help lead regulatory efforts in order to obtain worldwide approval of the company's products and oversee a team of regulatory professionals.
Job Responsibilities:
*Develop and implement International regulatory strategies to facilitate the progress of programs in all phases of development
*Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
*Lead interactions with regulatory agencies for your projects and products
*Lead preparation and support review of CTAs, BLAs and MAAs in different regions around the world, including CMC, nonclinical, and clinical activities
*Support the company's commercial products
*Interact with Regulatory Affairs personnel at partner companies
*Establish and meet timelines for regulatory submissions
*Maintain awareness and communicate with team members regarding changing regulatory requirements
Minimum Requirements:
*Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 8 years of increasingly responsible regulatory experience in the biopharmaceutical industry
*Deep and broad knowledge of worldwide regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals worldwide
*A proven track record of effective collaboration with regulatory agencies
*Demonstrated leadership success in management, including building and/or leading a regulatory affairs team or department
*Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
*Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
*Some travel required
For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
