Regulatory Affairs Associate

Position: Regulatory Affairs Associate I
Job Title:

Regulatory Affairs Associate I / Technical Project Manager - Regulatory Affairs CMCJob Description

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…