Job Description

Company Overview:

Thor Life Sciences has partnered with a leading [biotechnology/pharmaceutical] company dedicated to developing innovative therapies to address unmet medical needs. We are committed to excellence in research, development, and regulatory compliance to bring life-changing products to patients worldwide.

Position Overview:

We are seeking a highly experienced Director of Regulatory Affairs – CMC to lead the development and execution of CMC regulatory strategies. This role will be responsible for ensuring compliance with global regulatory requirements, supporting product development and lifecycle management, and liaising with regulatory authorities. The ideal candidate will have a strong background in CMC regulatory affairs, with expertise in [biologics/small molecules/cell and gene therapy] and experience managing regulatory submissions across multiple markets.

Key Responsibilities:

• Develop and implement global CMC regulatory strategies to support product development, registration, and post-approval changes.
• Lead the preparation, review, and submission of high-quality CMC sections of regulatory filings (IND/CTA, BLA/NDA/MAA, variations, supplements, annual reports, etc.).
• Provide strategic regulatory guidance to cross-functional teams, including R&D, Quality, Manufacturing, and Clinical, to ensure alignment with regulatory expectations.
• Serve as the primary point of contact with health authorities for CMC-related matters, including meetings, queries, and negotiations.
• Monitor and interpret global CMC regulatory requirements, trends, and guidelines to ensure compliance and assess potential impact on company projects.
• Lead interactions with external partners, CMOs, and contract laboratories to ensure regulatory compliance of outsourced activities.
• Support due diligence and business development activities by assessing regulatory risks and opportunities.
• Mentor and develop junior regulatory professionals within the organization.

Qualifications & Experience:

• Advanced degree (Ph.D., Pharm.D., or M.S.) in chemistry, pharmaceutical sciences, or related field preferred.
• Minimum of [10+] years of experience in Regulatory Affairs, with a strong focus on CMC.
• Proven track record of successful regulatory submissions and interactions with global health authorities (FDA, EMA, MHRA, PMDA, etc.).
• In-depth knowledge of CMC regulatory requirements, ICH guidelines, and global regulations.
• Experience with [biologics/small molecules/cell and gene therapy] CMC development and lifecycle management.
• Strong leadership, strategic thinking, and problem-solving skills.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.

Job Tags

Similar Jobs