Director – US RA CMC Team Leader, Global CMC Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the US Regulatory Affairs CMC team by establishing priorities and facilitating the successful delivery of high-quality regulatory strategies and submissions.

• Offer strategic leadership in US CMC regulatory matters throughout development and lifecycle activities.

• Supervise the preparation, review, and submission of CMC sections for US regulatory applications, amendments, supplements, and responses to inquiries from health authorities.

• Collaborate with Global CMC Regulatory Affairs teams and cross-functional groups, including technical development, manufacturing, quality, and supply.

• Counsel project teams regarding US regulatory requirements, associated risks, and potential opportunities.

• Foster and enhance innovation within CMC regulatory processes, tools, and methodologies.

• Represent the organization in discussions with US health authorities.

• Keep abreast of changes in US CMC regulations and guidance, communicating pertinent developments to the team.

• Cultivate team capabilities through coaching, feedback, and knowledge-sharing initiatives.

• Assist with approved veterinary products, ensuring CMC compliance, managing lifecycle strategies, overseeing post-approval strategies, technology transfers, site strategies, manufacturing adjustments, product and process enhancements, and global innovation strategies for pipeline programs.

⛳️ Requirements

• Extensive experience in CMC Regulatory Affairs, including significant involvement in US regulatory submissions and product lifecycle activities.

• Strong understanding of US CMC regulations, guidance, and health authority expectations.

• Proven experience in leading, developing, or mentoring regulatory professionals and coordinating complex, cross-functional projects.

• Demonstrated capability to shape regulatory strategy and provide clear, risk-based guidance on intricate CMC issues.

• Background in managing submission planning, content review, and responses to health authority inquiries.

• Enthusiasm for driving innovation and continual improvement in regulatory processes and operations.

• Exceptional written and verbal communication skills, with the ability to influence and collaborate across various teams and organizational levels.

• Strong organizational abilities to handle multiple priorities in a dynamic environment.

• Relevant scientific degree; BS/MS/Ph.D. in a scientific discipline such as Biology, Biochemistry, Chemistry, or Bioengineering.

• Significant industry experience in CMC regulatory affairs, particularly in innovation and product development.

• Regulatory exposure in global regions is mandatory.

🏝️ Benefits

• Competitive salary