An internationally known biotechnology company has an opening for a Manager / Senior Manager CMC job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. The regulatory CMC Biotech job - Manager or Senior Manager role with a leading global biotech based within commuting distance of London, Bucks, Berks, Surrey and Middlesex. A full lifecycle CMC strategy position focused on assisting this prestigious company to bring more lifesaving medicines to market in many areas of unmet medical needs.
- Lead the development, implementation, and influence of CMC regulatory strategy.
- Identify and assess global regulatory risks and mitigations
- Develop global agency meeting engagement plans
- Support and/or act as the global CMC regulatory contact with relevant regulatory authorities
- Coordinate all CMC aspects of global regulatory submissions and submission strategy.
Skills and Requirements:
- A minimum of 6-10 years strategic global regulatory CMC, or relevant experience
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
- Curiosity and passion for new manufacturing technologies
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including R&D, quality, compliance, technical development, process chemistry, manufacturing, and external partners/collaborators.
- A passion for product development and the patients who we serve.
- Demonstrate effective cross functional and cross-cultural skills including ability to impact industry/agency organization decisions.
- Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively and demonstrate optimism and energy in the face of change and adversity.
- Ability to work both independently with minimal direction and within project teams to attain group goals and key project milestones.
- Ability to represent the department in project teams.
- Demonstrate ability to assess and provide strategic guidance and impact organizational effectiveness including across cross functional teams.
- Demonstrate strong skills to organize, prioritize, and execute.
- Experience in interfacing with relevant global regulatory authorities.
- Experience and knowledge in the preparation of major global regulatory submissions including license applications, supplements/variations, and amendments.
- Knowledge and understanding of applicable global regulations.
- Experience and knowledge in biologics and/or proteins.
- Computer literate.
- BA/BS/University degree in Life/Health Sciences required.
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 David Nixon on +44 203 078 9544 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.