Senior Director, CMC Regulatory Affairs.
Major pharmaceutical company based in Hampshire
Employment Type: Permanent
Our client is seeking key talent to lead their CMC regulatory affairs team. Based in the UK, this company has seen steady growth since its inception 20 years ago. It is known for its drive, flexibility and brave approach to drug development. This new role is crucial to the continued international development of our client, and they will only be considering candidates with impeccable CMC reg affairs experience and who can demonstrate the contributions they have made to successful drug development at previous companies. Our client is seeking an individual who has the knowledge to map future international issues in reg affairs and build a team to respond to these issues before the competition.
Responsible for driving and ensuring a coordinated strategic global approach to CMC throughout all phases of development and registration (pre-IND to market support).
Responsible for the regulatory CMC strategy for potential in-licensing assets as part of the business development process.
Responsible for all regulatory agency interactions on CMC aspects, globally.
Lead, build, motivate and develop a team of CMC regulators.
Ensure a global coordinated consistent approach to CMC for all products at all phases of development and registration.
Lead the regulatory aspects related to chemistry, manufacturing and controls, for^new and existing products/projects. Ensure the development of robust, global CMC strategies to ensure identification of key issues. Leads the development of risk assessment and mitigation plans.
Provide regulatory senior leadership to the CMC regulators, setting a clear vision.
Ensure our client is implementing guidance and anticipating future landscape and trends.
Essential Skills & Qualification:
M.S. / Ph.D. in chemistry
Demonstrated experience in regulatory CMC at a senior level, including strategic development within a pharmaceutical company
Proven experience of leading a team at senior level and working and influencing remotely.
A balance of experience in development and commercial CMC regulatory activities in the US,^EU and other key international markets.
Software Competence: MS Office
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes, to US once / quarter
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: UK; Hampshire
Company Pension, Car Allowance, Life Insurance, Private Healthcare, Dental Care, Flexible Package Plan, Stock Options/Purchase Plan, Bonus, Free gym, Free Bus,
Keywords: Registration, Regulatory Affairs, MAA, CMC, Expert Reports, CPMP, Dossier, Regulatory Agency, Documentum, MHRA, EMEA, FDA, CFR21
Assigned Consultant: Avril Horn at CSL Recruitment on 01932 234686
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires^in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.