Milton Park Jobs - vacancies

 

Senior Regulatory affairs Manager

We are looking for a Senior Regulatory affairs Manager to work out of the new office in Cambridge and support the business with local clients there.  Reporting to the Regulatory Affairs Group Manager, you will function as a senior member of the Regulatory Affairs Department deputizing for the function head as required, providing high level scientific and technical advisory support services to clients of the company on matters concerned with the development and regulatory authority approval for marketing of medicinal products and devices. As a senior member of Constella’s professional staff, you will develop and maintain familiarity  with current industry practices that affect regulatory affairs in general; disseminate relevant information and intelligence to company personnel; assist and lead in the design and implementation of various high value solutions for clients, perform technical leadership and oversight to the project team in the area of  regulatory affairs, assume role of project team representative and leader, and assist in the development and implementation of training; serve as an active mentor to one or more junior staff members and provide training as requested by the functional leader.  If assigned direct reports, you will schedule and review project tasks; provide leadership in the delivery of services to clients; ensure staff fulfil their responsibilities in accordance with Constella’s policies, procedures and SOP’s, and ensure HR processes are properly implemented.  To be successful in this role, you will need to demonstrate a minimum of six years of employment related experience in regulatory affairs, a minimum of six years experience dealing with regulatory authorities in Europe or with the FDA, hold demonstrated project leadership/ managerial skills, and demonstrable skill in using computerised information systems, alongside a Life Science degree, pharmacy degree, medical or veterinary degree

To apply please send your CV to: recruituk@constellagroup.com