Regulatory Affairs | University of Pennsylvania

Skills & Competencies

Skills developed through this program

Auto-populatedfrom O*NET via SOC 11-9199.01

Skills

WritingReading ComprehensionActive ListeningSpeakingCritical ThinkingSystems EvaluationComplex Problem SolvingJudgment and Decision Making

Knowledge

English LanguageLaw and GovernmentAdministration and ManagementBiologyEducation and Training

Abilities

Written ExpressionOral ComprehensionWritten ComprehensionOral ExpressionDeductive ReasoningInductive ReasoningProblem SensitivityNear VisionSpeech RecognitionSpeech Clarity

Tasks

Develop regulatory strategies and implementation plans for the preparation and submission of new pro
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness,
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new products.

Technology

Document management softwareAnalytical or scientific softwareCompliance softwareData base user interface and query softwareInformation retrieval or search software

Tools

Computer laser printersDesktop computersLaptop computersLaser facsimile machinesMulti-line telephone systemsPersonal computersPhotocopying equipment

Work Values

AchievementIndependenceWorking ConditionsSupportRecognitionRelationships

Career Pathways

Occupations this program prepares you for

Auto-populatedfrom O*NET + BLS

Occupations matched to this program, with median wage, top wage, growth, and openings
SOC	Occupation	Method	Wage	Growth	Openings
Match confidence: medium11-9199.01	Regulatory Affairs Managers	title_inference	—	—	—

Program Pathways

Credentials this program stacks toward

No program pathways.

What You'll Learn

Key competencies developed through this program

Auto-populatedfrom NSX Competency Framework

Mastery: proficient (Level 3)(based on Post-Baccalaureate Certificate)

Regulatory strategies and implementation plans — develop autonomously for new and complex products, integrating scientific, legal, and commercial considerations across domestic and international markets.
Full regulatory agency submission packages — direct preparation and filing, ensuring timeliness, accuracy, and compliance with all applicable standards without supervisory review.
Non-routine product complaints and regulatory violations — investigate thoroughly, determine reportability, and prepare detailed documentation for submission to competent authorities.
Agency responses on product information and emerging issues — provide authoritative, technically sound replies that protect product approvals and company standing.
Regulatory guidance to development teams — deliver proactively on design controls, clinical evidence requirements, and marketing claims throughout the product lifecycle.
Audits and regulatory inspections — manage end-to-end, coordinating cross-functional responses and directing corrective action plans post-inspection.
Product recall activities — lead regulatory notification, reporting, and documentation processes in coordination with quality and supply chain functions.
Risk management and analytical software — apply to evaluate regulatory risk profiles and prioritize compliance investments across a product portfolio.
Complex regulatory problems — resolve using systems analysis and inductive reasoning to anticipate agency positions and adapt submission strategies accordingly.
Regulatory intelligence programs — establish and maintain to proactively identify legislative and guideline changes affecting current and pipeline products.

Program Details

Detailed information about this program

No detailed information available.

Requirements

What you need to earn this credential

No requirements listed.

Financial Aid

Eligible funding programs

No funding information available.

Scholarships

No scholarships listed.