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Regulatory Affairs Director
2 months ago
Job Summary:
Proclinical Group is seeking a highly skilled Regulatory Affairs Specialist to lead our team in managing regulatory proposal notifications, particularly for clinical trial submissions. As a key member of our team, you will support the development of customer-focused regulatory content and budgets, and collaborate with regulatory strategists to define and integrate bid content.
Key Responsibilities:
- Triage and Manage Regulatory Proposal Notifications: Triage incoming proposal notifications for the Regulatory Function, especially for clinical trial submissions, and ensure timely and effective management of these notifications.
- Develop and Maintain Regulatory Proposal Content and Budgets: Develop and maintain high-quality regulatory proposal content and budgets that meet client needs and strategic discussions.
- Collaborate with Regulatory Strategists: Collaborate with Regulatory Strategists to define bid content and integrate it into the bid strategy, ensuring seamless alignment with business development goals.
- Represent Global Regulatory Affairs: Represent Global Regulatory Affairs at business development meetings, providing expert insights and guidance to ensure proposals meet client needs and strategic discussions.
- Partner with Regulatory Function: Partner with the Regulatory function to ensure milestones and budgets are achievable, and provide input into regulatory strategy and timeline development for new study opportunities.
- Establish Company Standards: Assist in establishing company standards for high-quality submissions, ensuring consistency and excellence in regulatory proposal content.
- Support Regulatory Leadership: Support Regulatory leadership in monitoring performance and reporting key metrics, ensuring continuous improvement and optimization of regulatory processes.
- Participate in Corporate Quality Initiatives: Participate in corporate quality initiatives across business units, contributing to the development and implementation of quality standards and best practices.
Requirements:
- Education: Bachelor's degree or equivalent expertise in a scientific or healthcare discipline.
- Technical Skills: Proficiency in MS Office/Office 365.
- Language: Fluent in English.
- Regulatory Knowledge: Strong knowledge of regulatory activities, including submissions to Regulatory Authorities (e.g., INDs/CTAs, Scientific Advice Procedures, ODD, PIP, MAA/NDA, and post-approval submissions).
- Clinical and Pre-Clinical Study Results: Ability to understand and interpret clinical and pre-clinical study results for regulatory strategy.
