Senior Regulatory CMC Lead

Are you ready to lead cutting-edge regulatory affairs that accelerate breakthroughs in biotech?

Proclinical is seeking a Regulatory Affairs CMC Consultant to lead regulatory strategy and operations for global biologics development and registration. In this role, you will guide cross-functional teams, contribute to high-quality submissions, and ensure compliance with global regulatory requirements. This position offers the opportunity to work on innovative biologic products, including enzyme replacement therapies, in a collaborative and culturally diverse environment.

Responsibilities:

• Develop and implement regulatory CMC strategies for global submissions (e.g., IND, CTA, NDA, BLA, MAA).
• Lead and provide governance for regulatory CMC activities across early- and late-stage development and post-approval lifecycle management.
• Author, revise, and review CMC documentation, ensuring clarity, accuracy, and alignment with regulatory expectations.
• Offer strategic advice on complex technical and regulatory CMC topics, such as comparability, analytical control strategies, and process validation.
• Manage interactions with regulatory authorities, including agency meetings, responses to questions, and post-approval activities.
• Provide scientific, strategic, and editorial input to documents prepared by cross-functional teams.
• Collaborate with cross-functional leads to address emerging issues and improve business processes.
• Stay updated on evolving regulatory requirements and advise internal teams on their impact.

Key Skills and Requirements:

• Advanced degree in a scientific or engineering discipline (e.g., MS, PharmD, PhD).
• Expertise in regulatory CMC for biological medicinal products, including hands-on experience with CTD Module 3 authoring and review.
• Strong knowledge of global regulatory requirements (FDA, EMA, MHRA) and CMC expectations.
• Proven ability to deliver high-quality regulatory documents and influence regulatory authorities.
• Exceptional written and oral communication skills in English.
• Experience with enzyme replacement therapies or rare-disease biologics is highly desirable.
• Familiarity with major global filings, health authority interactions, and post-approval lifecycle activities.