Key Responsibilities and Required Skills for a Regulatory Coordinator

🎯 Role Definition

A Regulatory Coordinator is a pivotal team member who acts as the organizational backbone for all regulatory activities. This role is crucial for ensuring that products, processes, and documentation meet the stringent requirements set by governmental and regulatory agencies. You will be the central point of contact for regulatory submissions, tracking, and compliance, effectively bridging the gap between product development, quality assurance, and legal standards. This position requires meticulous attention to detail, exceptional organizational skills, and the ability to navigate complex regulatory frameworks to support the successful lifecycle of a product from conception to market.

📈 Career Progression

Typical Career Path

Entry Point From:

Regulatory Assistant or Associate
Quality Control / Quality Assurance Associate
Clinical Research Assistant

Advancement To:

Senior Regulatory Coordinator
Regulatory Affairs Specialist
Regulatory Affairs Manager

Lateral Moves:

Quality Assurance Specialist
Clinical Trial Associate or Coordinator

Core Responsibilities

Primary Functions

Prepare, coordinate, and assemble complex regulatory submissions, including new applications, amendments, supplements, and annual reports for submission to regulatory bodies like the FDA, EMA, Health Canada, etc.
Serve as the primary point of contact for day-to-day regulatory inquiries and provide guidance on submission requirements and compliance issues to internal teams.
Meticulously track all regulatory submission and correspondence records, ensuring all filings are up-to-date and easily accessible in the regulatory information management system (RIMS).
Maintain a deep and current understanding of relevant domestic and international regulations, guidelines, and standards, and communicate changes to impacted cross-functional teams.
Review and approve promotional materials, product labeling, and other marketing content to ensure full compliance with regulatory standards and prevent off-label promotion.
Assist in the development and implementation of internal regulatory policies, standard operating procedures (SOPs), and best practices to enhance organizational compliance.
Coordinate and manage communications with regulatory agencies, including responding to inquiries, requests for additional information, and formal queries.
Support regulatory inspections and audits by preparing necessary documentation, coordinating with subject matter experts, and assisting with follow-up on any findings or observations.
Manage and maintain essential regulatory documentation, including establishment registrations, product listings, and necessary licenses or permits.
Collaborate with clinical, non-clinical, and manufacturing teams to gather the required documentation and data needed for comprehensive regulatory filings.
Ensure that product changes are properly evaluated for regulatory impact and that all necessary submissions are filed and approved before implementation.
Prepare and submit documentation for Institutional Review Board (IRB) or Ethics Committee (EC) review and approval, ensuring the protection of human subjects in clinical trials.
Monitor and manage timelines for regulatory submissions, ensuring all deadlines are met and proactively identifying potential risks or delays.
Support post-market surveillance activities by assisting in the preparation of periodic safety reports and managing complaint handling from a regulatory perspective.
Facilitate the process for obtaining Certificates of Foreign Government (CFG) or Certificates of Pharmaceutical Product (CPP) to support international product registration.

Secondary Functions

Support ad-hoc data requests and exploratory analysis related to regulatory compliance metrics and submission performance.
Contribute to the organization's broader quality and compliance strategy by providing a regulatory perspective.
Collaborate with supply chain and logistics units to ensure regulatory requirements for shipping and importation are met.
Participate in project team meetings for new product development, providing early regulatory intelligence and strategic input.
Assist in training new team members and other departments on fundamental regulatory processes and compliance requirements.

Required Skills & Competencies

Hard Skills (Technical)

Regulatory Knowledge: Proficient understanding of GxP (GMP, GCP, GLP) and specific regulations such as 21 CFR, FDA guidelines, ICH guidelines, and/or international standards (e.g., EU MDR/IVDR, ISO 13485).
Submission Formatting: Experience with electronic Common Technical Document (eCTD) structure and proficiency with e-submission software and platforms.
Document Management: Expertise in using Regulatory Information Management Systems (RIMS) and Electronic Document Management Systems (EDMS) like Veeva Vault, SharePoint, or MasterControl.
Technical Writing: Ability to author and review complex technical and scientific documents with clarity, precision, and accuracy for a regulatory audience.
Project Management Software: Familiarity with tools like MS Project, Smartsheet, or Jira to track submission timelines and project milestones.

Soft Skills

Attention to Detail: An unwavering eye for detail is non-negotiable, as even minor errors in regulatory submissions can cause significant delays and issues.
Organizational Skills: Exceptional ability to manage multiple projects, documents, and deadlines simultaneously in a fast-paced environment.
Communication: Strong written and verbal communication skills to interact effectively with internal teams, stakeholders, and regulatory agencies.
Problem-Solving: Proactive and resourceful in identifying potential regulatory hurdles and collaborating with teams to find compliant solutions.
Interpersonal Skills: The ability to build strong working relationships with cross-functional partners in R&D, Quality, Manufacturing, and Marketing.
Adaptability: Capacity to adapt to evolving regulatory landscapes and shifting project priorities without losing focus on compliance.

Education & Experience

Educational Background

Minimum Education:

A Bachelor's degree is required.

Preferred Education:

A Master's degree in a related field or a Regulatory Affairs Certification (RAC) is highly desirable.

Relevant Fields of Study:

Life Sciences (Biology, Chemistry, Biochemistry)
Biomedical Engineering
Pharmaceutical Sciences

Experience Requirements

Typical Experience Range:

2-5 years of direct experience in a regulatory affairs role within the pharmaceutical, biotech, or medical device industry.

Preferred:

Experience with direct submission preparation (IND, NDA, BLA, 510(k), PMA) and interactions with a major regulatory agency (e.g., FDA).