Regulatory Affairs Project Manager – Small Molecule

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. Key Responsibilities • Manage regulatory projects for Small Molecule products across development and commercialization stages. • Coordinate preparation and submission of IND, NDA, ANDA, and other regulatory filings. • Drive regulatory reputed company and lifecycle management activities. • Collaborate with CMC, QA, Clinical, R&D, and Manufacturing teams. • Ensure submissions reputed company with FDA, EMA, ICH, and global regulatory guidelines. • Manage eCTD publishing and submission timelines. • Track regulatory commitments, risks, and project deliverables. • Support change controls, labeling updates, and health authority responses. • Lead cross-functional meetings and reputed company project status updates to stakeholders. Required Skills & Qualifications • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or reputed company 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. Apply tot his job Apply To this Job