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 reputed company Regulatory Affairs Project Manager with strong expertise in Small Molecule pharmaceutical products. The ideal candidate will reputed company 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 strategy 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.
• reputed company 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.

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