What are the responsibilities and job description for the Senior Director of Regulatory Affairs position at Thor Companies?
We are seeking an experienced and dynamic Senior Director of Regulatory Affairs – CMC to lead and strategize regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) across global markets. This leadership role will ensure compliance with regulatory requirements, drive innovative solutions for CMC challenges, and collaborate cross-functionally to support the development, registration, and lifecycle management of our product portfolio.
The ideal candidate will bring a strong background in regulatory affairs, particularly in CMC, combined with exceptional leadership skills and a track record of successfully navigating complex regulatory landscapes.
Strategic Leadership
- Develop and implement global CMC regulatory strategies to support the development, registration, and post-approval changes for drug and biologic products.
- Provide expert guidance on regulatory requirements, trends, and best practices for CMC in key markets (e.g., FDA, EMA, MHRA, PMDA).
- Partner with R&D, manufacturing, quality, and clinical teams to ensure alignment of CMC activities with overall regulatory and business strategies.
Regulatory Submissions and Compliance
Operational Management
