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 strategy and lifecycle management activities.
• Collaborate with CMC, QA, Clinical, R&D, and Manufacturing teams.
• Ensure submissions comply 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 provide project status updates to stakeholders.

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.