Job Description

Overview

Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking an experienced and strategic Associate Director, Regulatory Affairs to lead global regulatory efforts across early and late-stage programs.

This role will be instrumental in shaping and executing regulatory strategies from pre-IND through BLA and beyond, while ensuring full compliance with global regulatory requirements. The Associate Director will represent Regulatory Affairs across internal and external stakeholders, provide regulatory leadership on cross-functional teams, and contribute to long-term development planning.

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

• Bachelors degree in Life Sciences, Biotechnology, Pharmacy, or related field required; advanced degree (MS, PhD, PharmD) preferred
• Minimum of 68 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

Compensation

The expected base salary range for this position is $175,000 to $185,000.

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Job Tags

Similar Jobs