Senior Regulatory CMC Strategy Lead

Opus-Regulatory; Miami (FL); On-site; USD 170,000 - 250,000; Full time

Job summary

Opus Regulatory, a leading regulatory consultancy, seeks a Principal Consultant, Regulatory CMC in the United States to drive risk-informed CMC strategies across product lifecycles. You will lead cross-functional teams, guide health authority interactions with FDA/ EMA, and shape submission content and regulatory commitments.

The role requires senior expertise in Regulatory CMC, experience with multiple modalities, and a proven track record in developing and leading regulatory submissions and

Qualifications

• Bachelor’s degree in a scientific, technical, engineering, or related discipline.
• Minimum of 15 years of progressive pharmaceutical or biotechnology industry experience, including at least 10 years focused on Regulatory CMC.
• Demonstrated ability to independently develop and lead CMC regulatory strategies for complex drug and/or biologic development programs.
• Direct experience interacting with FDA and leading CMC health authority meetings and major regulatory submissions.
• Experience across at least two product modalities (e.g., small molecules, monoclonal antibodies, conjugates, vaccines, cell therapies, or gene therapies).
• Strong knowledge of US and ICH CMC regulatory requirements, CTD structure, and strategic/operational application.

Responsibilities

• Serve as a senior Regulatory CMC advisor to client teams, providing tailored guidance on CMC development, manufacturing, analytical and control strategies, regulatory submissions, and health authority interactions.
• Develop and implement risk-informed CMC regulatory strategies aligned with client’s product development, commercialization objectives, program risks, and organizational needs.
• Translate technical data, development decisions, and manufacturing changes into clear regulatory strategies and submission plans.
• Proactively identify CMC regulatory risks, gaps, and critical dependencies and recommend practical mitigation strategies.
• Lead CMC regulatory planning and content strategy for health authority meeting packages, INDs, IMPDs, NDAs, BLAs, MAAs, amendments, annual reports, supplements, and variations.
• Author, review, and provide strategic oversight of Module 3 content and other complex CMC regulatory and technical documents.
• Lead preparation for and participation in CMC meetings and other interactions with FDA, EMA, and other health authorities, as applicable.
• Direct the development of responses to health authority questions and requests for information in collaboration with cross-functional technical teams.
• Advise clients on comparability, change management, regulatory commitments, CMC compliance, and post-approval lifecycle strategies.
• Represent Regulatory CMC on cross-functional teams and partner effectively with Process Development, Manufacturing, Analytical Development, Quality, Supply Chain, and other functions.
• Monitor evolving CMC regulatory requirements, guidance, and precedents and translate them into actionable recommendations for clients.
• Build trusted client relationships and identify opportunities for Opus to provide additional support, as appropriate.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Client-facing communication

Education

Bachelor’s degree

Advanced degree

Job description

Opus Regulatory, a leading regulatory consultancy, seeks a Principal Consultant, Regulatory CMC in the United States to drive risk-informed CMC strategies across product lifecycles. You will lead cross-functional teams, guide health authority interactions with FDA/ EMA, and shape submission content and regulatory commitments.

The role requires senior expertise in Regulatory CMC, experience with multiple modalities, and a proven track record in developing and leading regulatory submissions and