Our client, a world class pharmaceutical company driven by research and development, strives towards better health for individuals by developing safe, effective and innovative pharmaceutical products and now ranks as the fastest-growing among the UK''s top 50 pharmaceutical companies. They are seeking a Regulatory Affairs Manager for a 6 month contract at their South East UK location.
The Regulatory Affairs Manager will be the regulatory lead for a marketed product licensed through the Centralised Procedure. In addition, you will also support the team for an ongoing paediatric development as well as support the preparation of an MAA for a product currently in phase III with a planned submission.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Familiar with the PIP process
Strong MAA and marketing products background
Experience of agency liaison and effective EMA working
PERSONAL SKILLS & ATTRIBUTES:
Strong communication, influencing and collaboration skills
Strong project management skills
BENEFITS OF THE ROLE: This is one of the fastest growing pharmaceutical companies in the industry known for a culture that supports a unique work environment and encourages employees to focus on collaboration and personal development. The company values its staff and provides the framework to bring out the best in everyone, viewing investment in them as key to their success. You can earn an excellent remuneration for this role and enjoy all the benefits of a central London lifestyle.
Fforde is acting as a recruitment agency/business.
KEYWORDS: Regulatory Affairs, Clinical Research, Clinical Trial, Clinical Study, Drug Development, PIP, EMA, MAA, Degree, Project Management, Paediatric, Pharmaceutical, South East UK.