Director, Global Regulatory Affairs Strategy job in Cranbury
|Employer:|| Amicus Therapeutics|
|State:||New Jersey (NJ)|
Director, Global Regulatory Affairs Strategy - Early Development
Summary of Position
The Director, Global Regulatory Affairs (GRA) Regulatory Strategy - Early Development is responsible for development/ implementation of innovative, tactical and global strategic regulatory planning (including small molecule, biologics, gene transfer) to product development teams in order to address the unmet medical need for patients with rare disease(s).
Roles and Responsibilities
The Director, Global Regulatory Affairs (GRA) Regulatory Strategy - Early Development is responsible for:
- Focus on providing oversight of nonclinical and clinical aspects of drug development and associated global regulations for assigned program(s);
- Participate as GRA representative to product development teams, communicating regulatory requirements supporting global product approval for assigned program(s);
- In collaboration with senior management and product development team, will develop a formal regulatory strategic plan, establish a regulatory advice/position statement on key development issues, and develop an alternative plan and mitigation strategy to address identified regulatory risks;
- Work collaboratively with the International GRA team (including JPN, US, EU), and be responsible for preparation, implementation of global regulatory strategies for assigned program(s), including resolution of critical regional conflicts for a unified consensus global development program(s);
- Work collaboratively with Product Development Team Lead and functional area representatives to the Product Development Team to provide strategic regulatory input to key development documents and study reports, as required, and ensure that key deliverables supporting regulatory strategy are provided in alignment with program timelines and management expectations;
- Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level. Play a key role in development and implementation of appropriate systems, processes and standards within GRA as assigned;
- Provide direction to Senior Leadership Team and Product Development Teams on emerging trends, regulations and changes, with emphasis on those related to rare disease drug development; provide assessments and feedback on new regulations and regulatory guidance, as requested.
- Reports to Director/Sr. Director, Global Regulatory Affairs