Clinical Regulatory Associate
Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their global regulatory team on a permanent basis. As Clinical Regulatory Associate you will be accountable for the US and Canada regulatory strategies that support the expedited delivery of safe and effective products to patients.
Responsibilities:
1. Assist the Regulatory Scientist in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/Health Canada meetings and regulatory trends
2. Review and summarize, information regarding regulator expectations by utilizing agency feedback received and knowledge of competitor labelling
3. Monitor upcoming and recent approvals of competitive programs
4. Communicate and share key information to enable seamless execution of US/Canada regulatory strategy
5. Communicate the regulatory options and impact on proposed product development plans, seeking Regulatory Scientist and management alignment
6. Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation
7. Support strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions in collaboration with Regulatory Scientist. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling
8. Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments
9. Determine and communicate submission and approval requirements and regulator expectations
10. Assist Regulatory Scientist to generate regulatory documents for submissions
11. Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems
12. Provide high quality, timely and decisive regulatory advice, in collaboration with the Regulatory Scientist, that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development
13. Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management
14. Execute high quality communications with FDA, Health Canada and internal customers to articulate and ensure understanding of the regulatory strategy in partnership with Regulatory Scientist
Requirements:
15. Bachelor’s degree in scientific or health sciences discipline
16. Preferred industry-related experience in regulatory affairs and/or drug development experience for 2 years
17. Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
18. Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required
19. Demonstrated ability to assess and manage risk in a highly regulated environment
20. Demonstrated strong written, spoken and presentation communication
21. Demonstrated negotiation and influence skills
22. Demonstrated attention to detail
23. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss