Our client is a leading global biopharmaceutical company. They are seeking a Senior CMC Regulatory Affairs Director for their offices in the South East
The Senior Director will be responsible for driving and ensuring a coordinated strategic global approach to CMC throughout all phases of development and registration (pre-IND to market support). Part of this role will include responsibility for the potential in-licensing assets as part of the business development process and for all regulatory agency interactions on CMC aspects, globally.
PRINCIPAL RESPONSIBILITIES include:
Leading, building, motivating and develop a team of CMC regulators
Ensuring a global coordinated consistent approach to CMC for all products at all phases of development and registration
Leading the regulatory aspects related to chemistry, manufacturing and controls, for new and existing products/projects
Ensuring the development of robust, global CMC strategies to ensure identification of key issues. Leads the development of risk assessment and mitigation plans
Providing regulatory senior leadership to the CMC regulators, setting a clear vision
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
M.Sc / Ph.D.
Solid Experience in regulatory CMC
Proven experience of leading a team at senior level and working and influencing remotely
Ideally a balance of experience in development and commercial CMC regulatory activities in the US, EU and other key markets
PERSONAL SKILLS & ATTRIBUTES:
Excellent communications skills
Availability to travel internationally
BENEFITS: This company is seeking talented, motivated and team oriented individuals who are keen to make a difference. They offer highly competitive salaries and comprehensive benefits which include: pension, health, company relocation, stock options on joining, and annual bonus.
Fforde is acting as a recruitment agency/business.
KEY WORDS: Regulatory Affairs, Director, Strategy, CMC, Regulatory, Drug Development, Drug Safety, Chemistry, Project Development, Project Management, Pharmaceutical, CRO, UK