Director, Regulatory Affairs (Biotech)

TL;DR

Director, Regulatory Affairs (Biotech): Developing and executing global regulatory strategies for cell therapy pipeline programs with an accent on IND, CTA, and BLA submissions. Focus on interfacing with the FDA and other health authorities to align pre-clinical and clinical development strategies.

Location: Hybrid in Somerset, New Jersey, United States. Applicants must be authorized to work in the US.

Salary: $193,629 - $254,137 USD

Company

Global biotechnology company advancing next-generation cell therapies for life-threatening diseases.

What you will do

• Develop and execute innovative global regulatory strategies for pipeline programs.
• Lead the preparation and submission of INDs, CTAs, BLAs, and related supplements.
• Interface with the FDA and other global health authorities to align development strategies.
• Represent Regulatory Affairs on global cross-functional development teams.
• Evaluate the need for in-vitro or companion diagnostic tests (CDx).
• Mentor junior team members and review promotional materials.

Requirements

• Pharm D or PhD Degree in a science or health care field.
• 7+ years of experience in regulatory affairs focusing on IND/CTA/BLA/MAA filing and approval.
• In-depth knowledge of global regulatory requirements for biologics and cell therapies.
• Proven ability to independently lead global regulatory strategies.
• Must be authorized to work in the United States.
• English proficiency required.

Nice to have

• Experience in cell and gene therapy.
• Experience in drug development for multiple myeloma.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match that vests fully on day one.
• 8 weeks of paid parental leave after 3 months of employment.
• Paid time off policy including vacation, personal, sick time, and 11 company holidays.
• Flexible spending and health savings accounts (FSA/HSA).
• Additional perks: legal assistance, pet insurance, and well-being initiatives.