Global CMC Regulatory Professional

12 Jan 2021
11 Feb 2021
Hendre Moolman
Regulatory Affairs
Full Time
Contract Type
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.

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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