Job Description

1 week ago Be among the first 25 applicants

This range is provided by GQR. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$165,000.00/yr - $200,000.00/yr

Key Responsibilities:

• Define and deliver regulatory strategy for assigned programs, ensuring alignment with clinical development plans
• Prepare and lead the submission of global clinical trial applications (INDs, CTAs) and future marketing applications (e.g., BLAs)
• Identify potential regulatory risks and proactively develop mitigation or contingency plans
• Ensure completeness, quality, and consistency across all regulatory submissions
• Stay current on evolving global regulations (FDA, EMA, ICH) and assess implications for programs
• Partner internally to influence regulatory planning and execution across disciplines

Qualifications:

• BA/BS in Life Sciences required; MS preferred
• 8–12 years of regulatory affairs and pharmaceutical development experience
• Strong experience preparing and leading global submissions for clinical and late-stage programs
• Knowledge of regulatory frameworks (FDA, EMA, ICH) and eCTD structure
• Excellent strategic thinking, communication, and cross-functional collaboration skills
• Ability to thrive in a fast-paced, science-driven environment

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing and Strategy/Planning

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at GQR by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Student loan assistance

Tuition assistance

Disability insurance

Get notified when a new job is posted.

Sign in to set job alerts for “Director of Regulatory Affairs” roles.

Waltham, MA $177,000.00-$336,000.00 1 week ago

Boston, MA $200,000.00-$300,000.00 1 day ago

Greater Boston $172,521.00-$249,862.00 3 days ago

Regulatory Affairs Director, Global Regulatory Strategy

Boston, MA $186,232.80-$279,349.19 2 weeks ago

Senior Director/Director of Regulatory Affairs

Senior Director, Global Regulatory Affairs

Greater Boston $210,000.00-$270,000.00 1 day ago

Pioneering Medicines: Senior Director, Regulatory Affairs

Vice President, Regulatory Affairs (Clinical)

Associate Director, Global Regulatory Affairs

Boston, MA $153,600.00-$241,340.00 2 weeks ago

Director, US Regulatory Affairs - Advertising and Promotion

Cambridge, MA $172,500.00-$249,166.66 1 day ago

Lexington, MA $264,200.00-$362,000.00 2 weeks ago

Director, Global Regulatory Affairs (GRA) – CMC

Executive Director, Regulatory Affairs & Quality Assurance.

Associate Director, Global Regulatory Affairs, Advertising and Promotion

Boston, MA $153,600.00-$241,340.00 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Job Tags

Similar Jobs