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
• 812 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

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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

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