Description
Coordinate and document regulatory activities for prescription and over-the-counter drugs, including audits, inspections, renewals, and registrations. Compile, publish, and manage eCTD submissions and lifecycle filings to health authorities to obtain and sustain approvals.
- • Provide technical review of CMC, nonclinical, and clinical data to ensure scientific rigor, accuracy, and clarity.
- • Review drug labeling, packaging, and promotional materials for compliance and manage FDA Form 2253 submissions.
- • Advise teams on premarket requirements, clinical trial compliance, import/export, and labeling obligations.
- • Compile and maintain regulatory documentation repositories and submission archives.
- • Coordinate cross-functional efforts for the preparation of regulatory dossiers and responses.
- • Determine required submission types for changes such as CMC updates, site transfers, or safety labeling updates.
- • Develop or conduct regulatory training for project, clinical, and commercial teams.
- • Maintain current knowledge of evolving FDA, EMA, and ICH regulations, standards, and guidance.
- • Obtain and distribute updates on domestic and international laws and agency expectations.
- • Participate in internal audits and host or support health authority inspections.
- • Prepare or direct preparation of responses to information requests, deficiency letters, and complete response letters.
- • Communicate with FDA, EMA, and other health authorities on pre-submission strategy, regulatory pathways, and submission queries.
- • Prepare, coordinate, or review eCTD submissions for IND/CTA, NDA/BLA/MAA, ANDA, supplements, and variations.
- • Interpret drug regulations and ICH guidelines and translate them into corporate policies and procedures.
- • Prepare and maintain registration files, licenses, and technical documentation to sustain approvals.
- • Recommend changes to procedures in response to new regulations or pharmacovigilance requirements.
- • Prepare responses to customer or partner requests for product data and regulatory statements.
- • Review clinical protocols and investigator brochures to ensure regulatory adequacy and data collection needs.
- • Write or update standard operating procedures, work instructions, and regulatory templates.
- • Coordinate recalls, market withdrawals, and field alert reports with Quality and Pharmacovigilance.
- • Develop or track regulatory and quality metrics such as submission timeliness and agency outcomes.
- • Direct or oversee collection of samples and batch documentation requested by authorities.
- • Review adverse event data and ensure timely ICSR, DSUR, and PSUR/PBRER submissions.
- • Manage serialization and DSCSA compliance for U.S. distribution, as applicable.
- • Ensure compliance with controlled substance scheduling and import/export permits, if applicable.
- • Manage pediatric plans (iPSP/PIP), orphan designation requests, and related commitments.
- • Identify and apply relevant guidance documents, pharmacopeial, and consensus standards.
- • Provide pre-, during-, and post-inspection support and track CAPAs to closure.
- • Recommend adjudication of product complaints and assess reportability and labeling impact.
- • Support development and maintenance of REMS or Risk Management 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
