Senior Director of Regulatory Affairs - Thor Companies : Job Details

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

• Oversee the preparation, review, and submission of high-quality CMC regulatory documents, including INDs, NDAs, BLAs, MAAs, and CTAs.
• Ensure compliance with current regulatory guidelines and proactively address potential risks or gaps in submissions.
• Lead interactions with global health authorities regarding CMC-related topics, including managing queries, inspections, and negotiations.

Operational Management

• Build, mentor, and lead a high-performing regulatory CMC team, fostering a culture of excellence, collaboration, and accountability.
• Implement efficient processes for managing regulatory timelines, data collection, and submission readiness.
• Monitor and interpret evolving regulatory landscapes, ensuring the company remains at the forefront of CMC compliance and innovation.