Associate Director, Regulatory Affairs (Biotech)

TL;DR

Associate Director, Regulatory Affairs (Biotech): Leading regulatory strategies and submission plans for novel biologics and drugs with an accent on early-phase development, IND applications, and interactions with regulatory authorities. Focus on managing complex submissions, providing regulatory impact assessments, and driving cross-functional collaboration to advance clinical development programs.

Location: Must be based in the US (Remote or Hybrid in Berkeley Heights, NJ; Frederick, MD; North Dartmouth, MA; or Fort Worth, TX).

Salary: $190,000–$200,000 USD

Company

A fully integrated, commercial-stage biotechnology company focused on developing treatments for central nervous system (CNS) and immunology conditions.

What you will do

• Act as the Regulatory Lead for investigational programs, providing expertise from nonclinical stages through marketing application.
• Prepare and coordinate regulatory documentation, including IND applications and amendments for first-in-human trials.
• Manage complex regulatory submissions by collaborating with cross-functional teams and external vendors.
• Provide regulatory impact assessments and strategic recommendations to senior management.
• Ensure compliance with GxP, SOPs, and occupational health and safety procedures.

Requirements

• Must be authorized to work in the US (no sponsorship provided).
• Bachelor’s degree in biological or pharmaceutical sciences.
• Minimum 7 years of experience in the pharmaceutical or healthcare industry.
• Minimum 5 years of experience in early and late-stage regulatory drug development.
• Strong knowledge of FDA, EU regulations, and ICH requirements.
• Proven leadership and project management experience with the ability to travel up to 20%.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Retirement savings 401k with company match and annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Flexible spending accounts, health savings accounts, and pet insurance.
• Career development and training opportunities.