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Regulatory Affairs Manager – Small Molecule

Remote • Posted 22 hours ago • Updated 4 hours ago

Full Time

No Travel Required

Able to Sponsor

Remote

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

NDA
Pharmaceutical Industry
Pharmacy
Project Management
Stakeholder Management
Pharmaceutics
Communication
Crystal Management Console
Quality Assurance

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: jeanmart
Position Id: 8976866
Posted 22 hours ago

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