Associate Director, Regulatory Affairs

Role Summary

Associate Director, Regulatory Affairs at Celldex, a clinical-stage biotechnology company developing antibody-based treatments for allergic, inflammatory, and autoimmune disorders. Lead global regulatory efforts across early and late-stage programs, shaping strategies from pre-IND through BLA and beyond, and represent Regulatory Affairs across internal and external stakeholders.

Responsibilities

• Develop, lead, and implement global regulatory strategies for assigned programs from early clinical development through registration and post-marketing activities
• Serve as the primary regulatory point of contact for one or more programs, including direct interactions with global health authorities (e.g., FDA, EMA), ensuring alignment of development plans and regulatory expectations
• Lead the preparation, review, and submission of key regulatory documentation including INDs, CTAs, BLAs, amendments, health authority briefing books, meeting requests, and responses to queries
• Represent Regulatory Affairs on cross-functional project teams, providing strategic input and ensuring regulatory considerations are fully integrated into development plans
• Collaborate closely with Clinical Development, CMC, Quality, and Program Management teams to ensure cohesive and aligned execution of regulatory deliverables
• Monitor and interpret evolving global regulatory requirements, guidelines, and competitive intelligence; assess impact on Celldex programs and advise internal stakeholders
• Lead and/or contribute to internal process improvements, SOP development, and inspection readiness initiatives to uphold high standards of regulatory quality and performance
• Mentor junior team members as the RA function continues to grow

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or related field required; advanced degree (MS, PhD, PharmD) preferred
• Minimum of 6–8 years of Regulatory Affairs experience in the biotechnology or pharmaceutical industry
• Demonstrated success in regulatory strategy development and execution, including global submissions (INDs, CTAs, BLAs) and regulatory health authority engagement
• In-depth knowledge of U.S. and international regulatory frameworks and guidelines (e.g., FDA 21 CFR, ICH, EMA)
• Proven ability to lead cross-functional regulatory efforts and communicate effectively with internal teams and external regulators
• Strong project management skills, attention to detail, and ability to manage competing priorities in a fast-paced, evolving environment
• Self-driven, proactive, and able to operate independently while fostering collaboration across departments

Education

• Include degree details as listed in Qualifications; advanced degree preferred