Director of Regulatory Science
1 week ago
Responsibilities:
- Responsible for the oversight and planning of all regulatory activities across the product portfolio.
- Act as key regulatory contact and interface with internal and external cross functional teams.
- Development of Request for Proposals and define scope of services for outsourced regulatory activities.
- Manage the assessment and selection of external regulatory providers.
- Provision of global regulatory strategic advice and operational support.
- Responsible for the authoring, review and management of key regulatory documentation for filing to Regulatory Agencies.
- Assist in the planning and execution of regulatory strategy for successful development of products including input and authoring of development plans and Target Product Profiles.
- Assist in development of cGMP manufacturing processes and controls and prepare regulatory documentation for GMP inspections.
- Maintain regulatory document management system and support regulatory compliance including the writing and maintenance of key regulatory SOPs.
- Support regulatory intelligence activities.
Skills and Attributes:
- Minimum of a Bachelor’s degree in life science, medical, or related field
- 8+ years regulatory experience
- Good knowledge of global regulatory requirements for the development of small molecules and biologics
- Proven ability in the writing of key regulatory documentation including CTAs, INDs, Scientific Advice requests and development plans
- Excellent knowledge of GXP across the development functions, ICH guidelines and appropriate regulations
- Excellent organisational, analytical, planning and project management skills and experience of overseeing regulatory external providers
- Demonstrated ability to liaise with key regulatory bodies and have comprehensive understanding of developing guidelines and regulatory trends
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