Global CMC Regulatory Professional

Location
Slough
Salary
Competitive
Posted
12 Jan 2021
Closes
11 Feb 2021
Ref
49593
Contact
Hendre Moolman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
CK Group are recruiting for a Global CMC Regulatory Professional to join a biopharmaceutical company on a contract basis for 12 months.

The Company:
This company is a world leading pharmaceutical company that focuses on neurology and immunology. Their ambition is to transform the lives of people living with severe diseases.

Location:
Flexible remote/home working is available for this CMC Regulatory position (small molecule).

The Role:
The main purpose of the role will be to
- Support for developing and implementing the regional CMC regulatory strategy and submission plans
- Identify supporting documents required for regional submissions and negotiates the delivery of approved technical source documents
- Write regional and global CMC documentation for submissions

Further responsibilities will include:
- Leading or providing support to all CMC related interactions to facilitate and ensure satisfactory resolution of CMC issues and negotiate CMC approvals
- Monitoring and reacting as appropriate to changes in the CMC regulatory environment in regions assigned for assigned projects/products
- Providing regulatory assessments for CMC changes and creation of entries and updates in the designated systems

To succeed in this role, you will come from a Life Science background with proven experience in regulatory CMC review, preferably with professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
- Knowledge of GMP requirements and standard systems
- Experience of direct communication and negotiation with regulatory agencies on CMC matters

Entitlement to work in the UK is essential. Please quote reference 49593 in all correspondence.

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