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Regulatory Affairs Project Manager

Job

HR Pundits

Remote

Full-Time

Posted 6 days ago (Updated 1 day ago) • Actively hiring

Expires 6/23/2026

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Job Description

Job Title:
Regulatory Affairs Project Manager - Small Molecule (20 Hrs/Week)
Location:
Remote Job Description We are seeking an experienced Regulatory Affairs Project Manager with strong expertise in Small Molecule pharmaceutical products. The ideal candidate will lead regulatory submission activities, coordinate cross-functional teams, and ensure compliance with global regulatory requirements. Required Skills & Qualifications Bachelor s or Master s degree in Pharmacy, Life Sciences, Chemistry, or related field. 10+ years of Regulatory Affairs experience in the pharmaceutical industry. Strong experience with Small Molecule products. Hands-on experience with IND, NDA, and ANDA submissions. Knowledge of FDA, EMA, ICH, GMP, and GxP guidelines. Experience in regulatory project management and cross-functional coordination. Strong communication and stakeholder management skills. Experience with eCTD submissions and regulatory systems/tools.

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