NonStop are working with a top pharmaceutical company to seek a Regulatory Manager based in Reading. Our client have an impressive product portfolio across their four business units. You will be responsible for managing a team of four and support major Diabetes and Cardiovascular brands.
This is a permanent positon and candidates must have regulatory pharmaceutical experience, ideally from a from big pharmaceutical company.
Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities, to high standards, to ensure that marketing authorisations are maintained in line with the company's plans and goals. Managing your own product list and supporting your team on their products
Develop strategic partnership with the Multi Country Organisation (MCO) Global Business Units to understand their priorities and align regulatory objectives of the MCO regulatory team to support the business. Attend Leadership meetings as required
Provide strategic input into development of lifecycle strategies for marketed products, both locally and in conjunction with Global Regulatory Affairs (GRA)
Input into review of promotional and non-promotional materials from a regulatory perspective, as required
Assist the Head of Regulatory Affairs in developing strategies to optimise the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project timeframes
Manage the workload and personal development of staff. Supervise and train other regulatory staff within department as required by the Head of Regulatory AffairsKey Qualifications/Experience:
A degree in science (preferably a life science), with record of proven success in achieving regulatory approvals in the UK and /or Ireland
Previous experience as a Regulatory Affairs Manager with direct line management and UK and Ireland approval expertise
Additional experience in the pharmaceutical industry in a related field is an advantage
A record of proven success in managing and supervising staff
Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines
Good organisational skills and ability to manage multiple projects/priorities under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities
Self-motivated with strong verbal and written communication skills. Able to communicate effectively and efficiently with other functional departments in the business
Good knowledge of the development process for medicines, and capable of critically reviewing and integrating scientific information from a variety of disciplines
An understanding of biosimilars and medical devices
If this role sounds like something you would be interested in, please send your CV, ideally in Word format, via this site.
If this role is not quite right for you but you would like to have a conversation about other roles, please search and connect with me, Nikita Sheth, on LinkedIn.
We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We're passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting, for more information, to browse all our roles, or to let us know how we can help you