Senior Manager, Growth Markets GRSO
CK Group are recruiting for the role of Senior Regulatory Affairs Manager, Growth Markets to join a Global Pharmaceutical company. Full working from home flexibility is available.
As a Senior Manager of Regulatory Affairs GRSO you will need to:Apply a broad knowledge and interpretation of regulatory requirements in Growth Markets and products to the drug development process, including promulgation of health authority marketing authorisation dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objective. Ensure that regulatory documentation meets relevant regulatory requirements and quality standards.
Key duties will include, but not limited to:
- Developing and implementing regulatory strategy for own functional area and region
- Leading issue resolution of regulatory risks by identifying escalating and monitoring issues
- Organising resources and processes across multiple teams/ functions to develop and deliver complete regulatory submissions within agreed timeframes
- Contributing to the planning, execution and assessment of product life cycle management activities and strategies
- Contributing to, and implementing, strategy for interactions and negotiations with health authorities
- Enhancing the capabilities of current resources (tools, systems, vendors, etc.) technologies, and processes for the team.
Resolving expense issues and manages costs of work teams before issues ariseYour Background:
Has experience in developing regulatory strategies for NDA's/ MAA's/ significant line extensions/ CMC lifecycle management
- BS/ MS in relevant field
- Experience in regulatory methods and processes in industry setting required
Apply:
Entitlement to work in the UK is essential. For more information or to apply for this Senior Regulatory Affairs Manager position, please contact Ashleigh Williamson on 01438 842 978 or email awilliamson@ckgroup.co.uk. Please quote reference 52381.iology position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52437.
It is essential that applicants hold entitlement to work in the UK.
IND180