Associate Director Regulatory Affairs

We are seeking a highly skilled Associate Director, Regulatory Affairs CMC with deep experience in biologics to join our Regulatory Affairs team. In this role, you will lead CMC regulatory strategy and execution for biologic programs across all stages of development and commercialization. You will work closely with Technical Operations, Quality, and external partners to ensure CMC data packages meet global regulatory requirements and support the successful advancement of innovative biologic therapies.

This position is ideal for a collaborative, detail-oriented regulatory professional who thrives in a science-driven environment and is passionate about enabling high-quality product development for patients in need.

Key Responsibilities

• Develop and implement global CMC regulatory strategies for biologic products, including monoclonal antibodies, recombinant proteins, or advanced biologics.
• Lead CMC content planning, authoring, and review for regulatory submissions such as INDs/CTAs , BLAs/MAAs , annual reports, amendments, and responses to health authority queries.
• Serve as the primary CMC regulatory representative on cross-functional teams, providing expert guidance on CMC requirements and risk mitigation.
• Manage and support interactions with global health authorities , including preparation of meeting briefing packages and coordination of regulatory communications.
• Monitor evolving global CMC regulations, guidelines, and industry expectations relevant to biologics.
• Ensure CMC documentation is compliant, scientifically sound, and aligned with development objectives.
• Contribute to manufacturing change strategies and lifecycle management planning.
• Mentor junior team members and help strengthen internal CMC regulatory processes and standards.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree (MS, PhD, PharmD) preferred.
• 8+ years of Regulatory Affairs CMC experience , with substantial focus on biologics .
• Demonstrated experience preparing and managing CMC sections of major global submissions (IND/CTA, IMPD, BLA/MAA).
• Strong understanding of biologics manufacturing, quality systems, analytical methods, and process development.
• In-depth knowledge of FDA, EMA, and ICH CMC guidelines and expectations.
• Excellent communication, leadership, and organizational skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities in a fast-paced environment.

Izvor: https://se.linkedin.com/jobs/view/associate-director-regulatory-affairs-at-meet-life-sciences-4349478887

Nivo: senior