CMC Regulatory Affairs（ Manager/Associate Director)

Henlius USA Inc.; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

Henlius USA Inc. seeks an experienced regulatory affairs leader to drive global CMC regulatory strategies for biologics from development through lifecycle management.

The Associate Director/Senior Manager will serve as a regulatory lead on cross-functional teams, guiding submissions to Health Authorities and ensuring compliance across regions with a focus on timely registrations and lifecycle optimization.

Qualifications

• Bachelor's degree in biological sciences or related field is required.
• Advanced degree preferred (MS/PhD/PharmD).
• Experience developing and leading global CMC regulatory strategies for biologics.
• In-depth knowledge of FDA/EMA/PMDA/NMPA/MHRA and ICH guidelines.
• Strong ability to lead cross-functional teams and manage priorities.

Responsibilities

• Lead development and execution of global CMC regulatory strategies from development to lifecycle management.
• Serve as Global Regulatory CMC lead on cross-functional project teams and influence key decisions.
• Prepare, review, and obtain approvals for high-quality CMC submissions (INDs/CTAs, BLAs/MAAs, variations).
• Support Health Authority interactions with briefing materials and regulatory questions.
• Provide regulatory assessments for manufacturing changes, analytics, and lifecycle activities.

Skills

Regulatory leadership

Cross-functional collaboration

Global CMC strategies

Biologics regulatory knowledge

Health Authority interactions

Project leadership

Attention to detail

Education

Bachelor's degree in Biological Sciences, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field

MS/PhD/PharmD preferred

Job description

Associate Director/Senior Manager, Regulatory Affairs (RA) - CMC

Henlius is seeking an experienced and strategic regulatory professional to join its expanding Global Regulatory Affairs CMC organization. The Associate Director/Senior Manager, Regulatory Affairs (RA) - CMC will lead/co-lead the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biological products across all stages of the product lifecycle. This individual will serve as the CMC regulatory lead/co-lead on cross-functional development teams, providing strategic guidance to ensure timely product development, successful global registrations, and ongoing regulatory compliance. The Associate Director will collaborate closely with internal stakeholders and global Health Authorities.

Responsibilities

• Lead/co-lead the development, implementation, and execution of global CMC regulatory strategies for biologics from early development through commercialization and lifecycle management.
• Serve as the Global Regulatory CMC Lead/co-lead on cross-functional project teams, providing strategic regulatory leadership and influencing development, manufacturing, quality, and commercial decisions.
• Lead the preparation, review, and approval of high-quality CMC regulatory submissions, including INDs/CTAs, BLAs/MAAs, supplements, amendments, variations, and responses to Health Authority requests.
• Support the Regulatory CMC aspects of Health Authority interactions, partnering with CMC subject matter experts to develop meeting strategies, briefing materials, and responses to regulatory questions.
• Provide regulatory assessments for manufacturing process changes, analytical methods, control strategies, comparability, technology transfers, and lifecycle management activities.
• Identify regulatory risks and develop proactive mitigation strategies to support product development timelines, product registrations, and regulatory compliance.
• Monitor evolving global CMC regulations, guidance documents, and industry trends, assessing their impact and ensuring organizational compliance.

Requirements

• Bachelor's degree in Biological Sciences, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree (MS, PhD, or PharmD) is preferred.
• Demonstrated experience developing and leading global CMC regulatory strategies for biologic products across multiple phases of development and/or commercialization.
• Extensive knowledge of global CMC regulations, ICH guidelines, and regional regulatory requirements (FDA, EMA, PMDA, NMPA, MHRA, and other international Health Authorities).
• Experience with Health Authority interactions, including preparation for regulatory meetings, briefing documents, and responses to regulatory questions.
• Strong understanding of biologics manufacturing processes, analytical characterization, process validation, comparability, control strategies, and Quality by Design (QbD) principles.
• Demonstrated ability to lead cross-functional teams, influence senior stakeholders, and manage multiple complex global projects simultaneously.
• Strong organizational skills with exceptional attention to detail and a demonstrated ability to prioritize competing deadlines in a fast-paced environment.