Regulatory CMC Expert in Biologics

Lead and provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and submissions for biologic products, including monoclonal antibodies, recombinant proteins, vaccines, and cell therapies. 

Interpret and apply global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) related to CMC aspects of biologics development, manufacturing, and commercialization. 

Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to develop and execute CMC regulatory strategies aligned with product development objectives. 

Prepare, review, and contribute to regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements. 

Provide regulatory assessment of CMC changes, deviations, investigations, and manufacturing investigations, ensuring compliance with regulatory requirements and guidelines. 

Support interactions with regulatory agencies, including preparation of briefing documents, responses to regulatory inquiries, and participation in agency meetings. 

Stay abreast of emerging regulatory trends, changes, and updates in the biologics industry and provide insights and recommendations to internal stakeholders. 

Serve as a subject matter expert on CMC regulatory requirements for biologic products, providing training and guidance to internal teams as needed. 

Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline, preferably in biochemistry, biotechnology, pharmaceutical sciences, or related field. 

Minimum of 5 years of experience in regulatory affairs with a focus on CMC for biologic products within the pharmaceutical or biotechnology industry. 

Deep understanding of global regulatory requirements and guidelines related to CMC aspects of biologics development, manufacturing, and commercialization. 

Experience with preparation and submission of CMC sections of regulatory documents, including INDs, BLAs, and MAAs. 

Strong technical background in biopharmaceutical manufacturing processes, analytical methods, and characterization techniques for biologic products. 

Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to internal and external stakeholders. 

Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for compliance. 

Regulatory affairs certification (RAC) or relevant professional certification (e.g., TOPRA Diploma) preferred but not required.