Regulatory CMC Documentation Specialist

REGULATORY CMC DOCUMENTATION ASSISTANT

6 MONTH CONTRACT

ALDERLEY PARK

REF: 108163

Jake Phillips is recruiting for a REGULATORY CMC DOCUMENTATION ASSISTANT to work on a 6 month contract with a global pharmaceutical company based at the company's current HQ in Alderley Park.

THE ROLE

The main responsibilities will include:

- Completes administrative tasks for a team producing regulatory CMC documentation at various stages of a products life cycle
- Maintains a working knowledge of regulatory CMC requirements and the drug development process
- Develops templates, databases and structured share file areas and consolidates information from other functions to support the timely delivery of regulatory CMC submissions

THE CANDIDATE

The successful candidate should have excellent IT skills, be familiar with handling large volumes of complex data and be able to adapt quickly to new IT and working processes. Candidates should also be able to demonstrate:

- Knowledge of the drug development process, product life cycle, and contents/formatting of regulatory submissions
- Scientific or related degree
- Experience in data management
- Keen to learn new skills
- Excellent attention to detail
- Excellent communication skills

If you are interested in joining a successful Regulatory department of a global pharmaceutical company we would be glad to hear from you.

THE COMPANY

Global biopharmaceutical company covering the full discovery life cycle of new medicines, through early- and late-stage development to manufacturing and distribution, and global commercialisation of primary care, specialty care-led and specialty care medicines that transform lives.

Primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease (CVMD); Oncology; and Respiratory, Inflammation and Autoimmunity (RIA). They are also active in the Infection, Neuroscience and Gastrointestinal (ING) disease areas.

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