Description
Plan, direct, and coordinate regulatory affairs to ensure products and quality systems comply with applicable regulations, standards, and SOPs.
- • Implement and monitor complaint handling and adverse event reporting systems.
- • Investigate product complaints and submit required reports to authorities.
- • Maintain up-to-date knowledge of applicable laws, guidance, and standards.
- • Manage audits, health authority inspections, CAPAs, and product recalls.
- • Monitor emerging regulatory trends and assess impacts on the business.
- • Oversee regulatory compliance for clinical trials and study protocols.
- • Prepare timely responses to health authority questions and information requests.
- • Represent the company before domestic and international regulatory agencies.
- • Review submission dossiers to ensure completeness, accuracy, and compliance.
- • Review labeling, promotional, and user information for regulatory compliance.
- • Train staff on regulatory policies, procedures, and submission practices.
- • Contribute regulatory input to business unit strategies and operating plans.
- • Coordinate regulatory aspects of investigations, subpoenas, or litigation with Legal.
- • Develop, maintain, and continuously improve SOPs and local work practices.
- • Establish and manage systems for electronic and paper publishing (e.g., eCTD).
- • Evaluate publishing tools and stay current on electronic submission requirements.
- • Build and maintain relationships with key regulators and industry groups.
- • Assess regulatory risks related to materials, labeling, claims, and sustainability.
- • Ensure regulatory documentation and records meet global standards and retention requirements.
- • Direct the preparation and submission of regulatory applications, reports, and correspondence.
- • Formulate and implement regulatory policies, SOPs, and work instructions.
- • Provide regulatory guidance to R&D, Quality, Clinical, and Marketing teams.
- • Communicate regulatory requirements across functions and ensure consistent interpretation.
- • Develop regulatory strategies and plans for new products, changes, and lifecycle management.
- • Set regulatory priorities, budgets, and resource plans.
Related specializations
Interview options
Interview options
Interviewee gender
Interviewee accent
Interview time
Related Pathways
Management & Entrepreneurship
View
Source
Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
Learn more
Sources & Standards:
This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
