Senior Regulatory CMC Lead / Senior Regulatory CMC Leadess

Join Our Team as a Regulatory Affairs CMC Consultant

Are you ready to lead cutting-edge regulatory affairs that accelerate breakthroughs in biotech? Proclinical is seeking a Regulatory Affairs CMC Consultant to spearhead regulatory strategy and operations for global biologics development and registration. In this pivotal 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 enhance 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.

If you are interested in applying to this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.