Regulatory Project Manager

Position Overview

Reporting to the VP of Quality, the Regulatory Project Manager serves as a cross-functional coordinator between operations, quality, and scientific teams. You will manage regulatory timelines, track submission status, and ensure project milestones align with applicable regulatory requirements across OTC monograph, cosmetic, and pharmaceutical (Rx/OTC) product lines.

This role is execution-focused, ensuring regulatory deliverables, labeling, and submissions are complete, compliant, and on time across multiple client projects. 

You will work at the intersection of Regulatory Affairs, Quality, R&D, and Manufacturing, ensuring projects meet FDA and global regulatory requirements while maintaining audit readiness. 

This is an excellent opportunity for candidates seeking to build or advance a regulatory career within a fast-paced, multi-client CDMO environment. You will gain hands-on exposure to FDA, Health Canada, and international regulatory frameworks while developing strong project management fundamentals and regulatory strategy expertise.

Key Responsibilities

Regulatory Project Execution

• Drive timelines and deliverables for regulatory projects across OTC, cosmetic, and pharmaceutical products across multiple client accounts simultaneously.
• Ensure submission packages, labeling, and supporting documentation are complete and inspection-ready.
• Track project milestones and proactively identify risks to timelines or compliance.
• Serve as a point of contact on regulatory project status updates; prepare meeting agendas, minutes, and action item trackers.

Cross-Functional Coordination

• Partner with Quality, R&D, Analytical, and Operations to align regulatory requirements with development and manufacturing activities.
• Ensure regulatory impact is assessed for changes, deviations, and product updates.
• Support the development and maintenance of regulatory strategies for new and existing products across OTC drug, cosmetic, and pharmaceutical categories.

Labeling & Compliance Oversight

• Coordinate labeling review to ensure compliance with 21 CFR (201, 101), OTC monographs, MoCRA requirements, FD&C Act, and fair packaging and labeling requirements.
• Support claims review and ensure alignment with FDA/FTC expectations.

Audit & Inspection Readiness

• Support regulatory and client audits by organizing documentation and tracking commitments.
• Assist in preparation of audit responses and ensure timely follow-up on regulatory commitments.
• Support client due diligence requests and internal compliance reviews as needed.

Regulatory Intelligence

• Monitor FDA guidance documents, Federal Register notices, and industry changes relevant to OTC monographs, MoCRA, and cGMP regulations.
• Translate regulatory updates into actionable internal recommendations; summarize and communicate impact to team leads.

Documentation & Systems

• Maintain and update regulatory documentation systems and project trackers.
• Generate status reports and dashboards for internal stakeholders.
• Contribute to the development and improvement of internal regulatory SOPs and project management templates.

Qualifications

Required

• Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or a related scientific or health field.
• 1–4 years of experience in regulatory affairs, project management, quality assurance, or a closely related function within pharma, biotech, cosmetics, or a CDMO/CRO environment.
• Working knowledge of FDA regulatory frameworks, including OTC drug monographs (21 CFR Parts 300–460), cosmetic regulations, and/or pharmaceutical drug approval pathways.
• Strong organizational and project coordination skills with demonstrated ability to manage multiple timelines and competing deadlines.
• Proficiency with Microsoft Office Suite; comfort learning new project management tools (Monday.com, Asana, Veeva, etc.).
• Excellent written and verbal communication skills; ability to distill complex regulatory information for non-regulatory stakeholders.
• High attention to detail and a quality-first mindset.

Preferred

• Experience in a CDMO or multi-client environment.
• Exposure to MoCRA (Modernization of Cosmetics Regulation Act) requirements and implementation timelines.
• Exposure to cGMP (21 CFR 210/211) and regulatory submissions or labeling.
• Experience with eCTD publishing, FDA ESG submissions, or document management systems (Veeva Vault, MasterControl).
• RAC certification (or in progress).

Core Competencies

Why Join Us

• Exposure to OTC, Rx, and cosmetic product categories across a diverse client portfolio.
• Hands-on experience with regulatory strategy and execution in a full-service CDMO environment.
• High-impact role with visibility across Quality, Regulatory, and Operations.
• Gain exposure to FDA, Health Canada, and international regulatory frameworks.
• Clear pathway to build a regulatory career with mentorship from senior regulatory professionals.