CMC Project Manager

Proclinical is seeking a CMC Project Manager to be based in Munich on a contract basis.

Job Responsibilities:

• Provide appropriate CMC manufacturing records and documentation to support regulatory submissions and inspections
• Communicate progress and identify risks and issues arising to the CMC lead and Project Teams as appropriate
• executing CMC regulatory strategies for new product developments
• Project managing new product developments.
• Experience in the preparation of Module 3 and 2.3 in eCTD & CTD format
• You will be managing Regulatory CMC and compliance project teams ensuring they follow relevant guidelines.
• Your role is to ensure you provide CMC Regulatory advice of high quality to client projects on a global scope
• Experience working on Development and Post-Approval stages
• Ability to act as liaison with other departments where necessary (internal and external bodies)

Skills and Requirements:

• Knowledge of cGMP and related regulatory guidelines governing the manufacture of biologics in the UK, EU & USA is desired
• Proficiency with MS Project is essential
• Exceptional communication, organizational skills & project management skills
• Strong communication skills and proven ability to work well in teams
• Enjoys working under pressure and meeting deadlines
• Knowledge of CP/MRP/DCP submission procedures

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.