CMC Regulatory Affairs Lead – Biologics
Location: Flexible / Remote
Industry: Biotechnology / Pharmaceutical
Function: Regulatory Affairs – CMC
Level: Mid–Senior
Are you ready to take a front seat in the development and life-cycle management of innovative large molecule therapeutics?
A leading biotech organization is seeking a highly motivated CMC Regulatory Affairs Lead to drive the preparation and management of CMC documentation for clinical and commercial submissions, with a primary focus on China. This role offers a unique opportunity to contribute strategically and operationally across the CMC landscape - from early development through to post-approval.
Key Responsibilities
* Lead the preparation of high-quality CMC documentation for clinical and commercial submissions in China, collaborating closely with global and local stakeholders.
* Drive and lead interactions with regulatory authorities in China (e.g., CDE), including preparation of scientific briefing packages and response documents.
* Oversee life-cycle management of CMC dossiers according to regional requirements and strategic objectives.
* Assess the regulatory impact of CMC-related changes and lead variation strategies and submissions.
* Ensure submission packages are complete, accurate, and compliant with country-specific and international regulatory requirements.
* Coordinate and oversee local quality control (QC) testing activities in collaboration with the global analytical CMC team.
* Manage and align deliverables from internal and external partners, ensuring priorities and timelines are met.
* Provide strategic input to ongoing CMC development programs.
* Track and ensure fulfillment of regulatory commitments.
Required Qualifications & Skills
* Advanced degree (MSc or PhD) in biotechnology, pharmaceutical sciences, bio-engineering, or a related field.
* Solid experience in CMC regulatory affairs, ideally with exposure to large molecule development.
* Strong understanding of global regulatory requirements including China NMPA, FDA, EMA, and ICH guidelines.
* Proven ability to lead CMC writing and dossier preparation, including briefing books and regulatory responses.
* Excellent communication and interpersonal skills; capable of building strong relationships across global cross-functional teams.
* Highly organized, detail-oriented, and able to manage multiple complex projects in parallel.
* Proactive, self-starter with a hands-on approach and problem-solving mindset.
* Fluent in English (written and spoken); knowledge of Mandarin is a plus but not required.
What’s on Offer
* The opportunity to shape regulatory strategies for first-in-class biologics in a global development setting
* Cross-functional collaboration with experienced teams and top-tier partners
* A dynamic and science-driven environment committed to innovation
* Career growth and leadership development in a high-impact role
Ready to lead the future of biologics CMC regulatory strategy?
Apply now to make your mark in global drug development.