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.
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