RA CMC Associate Manager
A job vacancy for a RA CMC Associate Manager has arisen at a leading global pharmaceutical company specialising in the development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates worldwide and has market leading products in multiple therapy areas.
- Under supervision and guidance, provide timely preparation of high-quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- Author high-quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- As needed, coordinate /collect/store source documentation needed for direct submission to Health Authorities.
- Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
Skills and Requirements
- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- Advanced Science Degree is desirable.
Experience in regulatory and/or pharmaceutical industry preferred.
- Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
- Fluent English required (oral and written). Excellent written/spoken communication skills.
Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
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 contact Keri Marshall at 0207 440 0679 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.