Regulatory CMC Documentation Specialist

REGULATORY CMC DOCUMENTATION SPECIALIST

6 MONTH CONTRACT

MACCLESFIELD

REF: 104119

Jake Phillips is recruiting for a REGULATORY CMC DOCUMENTATION SPECIALIST to work on a 6 month contract with a global pharmaceutical company based at the company's manufacturing site in Macclesfield.

THE ROLE

The main responsibilities will include:

- Support the CMC Documentation team
- Aid team members by updating document property metadata
- Assist in the checking of data integrity within the Regulatory Document Management System and in the Regulatory Submission Tracking System
- Contribute to the development of business processes as required
- Develops a working knowledge of regulatory CMC requirements and the drug development process
- May liaise with other functions to obtain information that supports the generation of regulatory documentation or the tracking of Regulatory Health Authority approvals
- Communicates and relays information to team members and immediate supervisor

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
- Experience in understanding CMC dossier structures and advanced knowledge of common file formats (eg, Word) and related publishing tools (eg, ISI Toolbox, Adobe Acrobat, eCTDXPress)
- Expertise in using Document Management Systems
- Knowledge of regulatory authorities requirements on electronic submissions in several regions (eg, US, Europe, etc.).
- Demonstrated ability to set and manage priorities, resources, goals and project initiatives.
- Experience working in cross-functional, global project teams.
- 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.

Hays Talent Solutions is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found on our website.