Responsibilities:
1. Responsible for the oversight and planning of all regulatory activities across the product portfolio.
2. Act as key regulatory contact and interface with internal and external cross-functional teams.
3. Development of Request for Proposals and define scope of services for outsourced regulatory activities.
4. Manage the assessment and selection of external regulatory providers.
5. Provision of global regulatory strategic advice and operational support.
6. Responsible for the authoring, review and management of key regulatory documentation for filing to Regulatory Agencies.
7. 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.
8. Assist in the development of cGMP manufacturing processes and controls and prepare regulatory documentation for GMP inspections.
9. Maintain regulatory document management system and support regulatory compliance including the writing and maintenance of key regulatory SOPs.
10. 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 organizational, analytical, planning, and project management skills and experience of overseeing regulatory external providers
* Demonstrated ability to liaise with key regulatory bodies and have a comprehensive understanding of developing guidelines and regulatory trends
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