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: advanced (Level 4)(based on Master's Degree)

Enterprise-wide regulatory strategy — set and align with long-term business objectives, guiding senior leadership on risk, market access, and policy positioning across global jurisdictions.
Organizational representation before major domestic and international regulatory agencies — lead on significant policy matters, product approvals, and enforcement proceedings that shape company standing.
Regulatory affairs function — build, resource, and continuously improve to sustain organizational capability against evolving regulatory landscapes.
Regulatory professionals and multidisciplinary teams — mentor, coach, and develop to elevate competency and succession readiness across the department.
Policy advocacy positions — craft and advance before industry associations and regulatory bodies to shape favorable regulatory frameworks for the sector.
High-stakes product recall and crisis response — direct regulatory communications strategy, executive briefings, and agency negotiations to protect public safety and company reputation.
Cross-functional alignment on regulatory requirements — lead at the executive level, ensuring R&D, legal, commercial, and manufacturing strategies reflect current and anticipated compliance obligations.
Regulatory submission governance standards — design and institutionalize to ensure consistency, quality, and defensibility of all filings across business units and geographies.
Organizational risk posture — evaluate using systems-level judgment and executive decision-making frameworks to prioritize regulatory investments and pre-empt enforcement actions.
Emerging regulatory technologies and data tools — champion adoption of advanced compliance, risk management, and document management platforms to drive efficiency and audit-readiness at scale.

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.