Regulatory Affairs Associate

Regulatory Affairs Associate I / Technical Project Manager – Regulatory Affairs CMC

This role serves as a Technical Project Manager within Regulatory Affairs CMC, focused on supporting marketed product variations and post-approval regulatory changes. You will work at the intersection of Regulatory Affairs, CMC, Manufacturing, Process Development, Analytical Sciences, and other technical functions to develop submission strategies, manage timelines, coordinate cross-functional activities, and ensure the timely delivery of high-quality regulatory submissions. The position is highly collaborative and requires strong project management skills, excellent communication abilities, and a foundational understanding of regulatory submissions, electronic Common Technical Documents (eCTD), and CMC documentation.

Responsibilities

• Manage regulatory activities related to marketed product variations and post-approval changes, ensuring compliance with applicable requirements.
• Compile, author, and manage Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions for assigned products and projects.
• Ensure CTD and eCTD content meets required structural, formatting, and regulatory standards for U.S. and international dossiers.
• Partner closely with Regulatory Affairs CMC Project Leads to develop Module 3 content and overall submission strategies.
• Coordinate the preparation of submission documents and responses to regulatory agency inquiries, working with subject matter experts across functions.
• Serve as the project manager for assigned regulatory initiatives, driving timelines, deliverables, and stakeholder accountability.
• Interface with subject matter experts in R&D, Manufacturing, Process Development, Analytical Sciences, Quality, and other technical groups to gather information and resolve issues.
• Independently facilitate project team meetings and document review sessions to keep projects on track and address open items.
• Monitor project progress, identify risks, and proactively adjust plans as priorities evolve to maintain delivery commitments.
• Ensure regulatory submissions are completed thoroughly, accurately, and on schedule with minimal oversight.
• Act as a central point of coordination between Regulatory Affairs and supporting functional groups to align expectations and deliverables.
• Communicate project status, risks, timelines, and action items clearly and regularly to stakeholders.
• Build strong working relationships with global teams to support successful regulatory filings in multiple regions.
• Coordinate cross-functional activities and documentation to support CMC-related activities within pharmaceutical development, manufacturing, and regulatory environments.
• Manage multiple projects simultaneously, prioritizing tasks effectively and maintaining high standards of organization and documentation.

Essential Skills

• Bachelor's degree in Chemistry, Biology, Life Sciences, or a related scientific discipline.
• 1–2 years of pharmaceutical industry experience.
• 1–2 years of cross-functional project management experience, preferably in a technical or scientific environment.
• Strong project management fundamentals, including timeline management, risk identification, and stakeholder coordination.
• Experience coordinating technical documentation and interacting with scientific subject matter experts.
• Working knowledge of regulatory submission components and eCTD structures.
• Experience working with electronic document management systems.
• Strong organizational skills with the ability to manage multiple projects simultaneously and work independently.
• Excellent communication skills, including the ability to influence and drive outcomes without direct authority.
• Strong attention to detail and a commitment to accuracy in documentation and submissions.
• Foundational understanding of Chemistry, Manufacturing, and Controls (CMC) documentation and processes.
• Ability to coordinate cross-functional teams and drive deliverables to meet regulatory timelines.

Additional Skills & Qualifications

• Experience in Regulatory Affairs, CMC, R&D, Manufacturing, Process Development, or Analytical Sciences.
• Familiarity with CTD and eCTD submission…