Senior Regulatory CMC Lead

Lead Regulatory Strategy for Global Biologics Development

Join a collaborative and culturally diverse environment to drive cutting-edge regulatory affairs that accelerate breakthroughs in biotech. This role focuses on leading regulatory strategy and operations for global biologics development and registration, including innovative products such as enzyme replacement therapies.

Key Responsibilities

• Develop and implement regulatory CMC strategies for global submissions, including IND, CTA, NDA, BLA, and 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 to ensure 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.

Essential Qualifications

• Advanced degree in a scientific or engineering discipline, such as MS, PharmD, or 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.
• Familiarity with major global filings, health authority interactions, and post-approval lifecycle activities.

Preferred Experience

• Experience with enzyme replacement therapies or rare-disease biologics.