1. Beyond Academia

2. What is the Regulated Product Industry?
The research, manufacture, and distribution of any product that falls under the jurisdiction of the Food and Drug Administration in the United States or a similar agency in another country.

3. What Does the FDA Regulate?
Food
Drugs
Biologics
Medical Devices
Radiation Emitting Electronics
Cosmetics
Veterinary Products
Tobacco
About 20% of the US economy
$2.4T per year

4. Regulated Life Science Industries
Drugs
Biologics
Medical Devices
Dietary Supplements

5. Functional Areas Within the Regulated Life Science Industries
Drug Discovery/ Development
Product Development
Project Management
Production/ Process Engineering
Quality Assurance/ Quality Control
Regulatory Affairs
Clinical Trials
Strategy
Licensing & Partnerships
Corporate Communications
Corporate Development
Supply Chain Management
Software Development
Finance
Marketing
Enterprise Resource Planning

6. Functional Areas Within the Regulated Life Science Industries
Drug Discovery/ Development
Product Development
Project Management
Production/ Process Engineering
Quality Assurance/ Quality Control
Regulatory Affairs
Clinical Trials
Strategy
Licensing & Partnerships
Corporate Communications
Corporate Development
Supply Chain Management
Software Development
Finance
Marketing
Enterprise Resource Planning

7. What is Regulatory Science?
Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.
Law
Science
Business

8. Post Market Surveillance
R&D
Core Functions of Regulatory Professionals
Risk Management
Crisis Management
Regulatory Strategy
Regulatory Operations
Due Diligence
Negotiation
Reimbursement
Clinical
Product Life Cycle
Distribution
Submission/
Registration
Advertising/
Promotion
Manufacturing
Labeling

9. Average Base Compensation by Job Level with Doctoral Degree
Director
$161,863
Manager
$133,302
Specialist
$88,515
Regulatory Affairs Professionals Society: 2016 Scope of Practice & Compensation Report for the Regulatory Profession

10. Regulatory Affairs Professional Employment Statistics
Base salaries have increased by an average of 3.3% per year since 1995
Regulatory Affairs Professionals Society: 2016 Scope of Practice & Compensation Report for the Regulatory Profession

11. Regulatory Affairs Professional Employment Statistics
Industry wide average of 22% bonus
Regulatory Affairs Professionals Society: 2016 Scope of Practice & Compensation Report for the Regulatory Profession

12. How Can You Transition into the Regulated Product Industry?
Expand your knowledge through formal and informal learning opportunities
Develop relationships with individuals that have leadership roles in the industry
Gain hands-on experience
Don’t forget your science

13. MS Regulatory Management
Designed to provide post-doctoral scientists and clinicians with the knowledge and skills necessary to become leaders in regulatory and clinical research
Advanced training in regulatory subsectors related to pharmaceuticals, medical devices, and clinical research, as well as knowledge and skills in business and management

14. Curriculum Regulatory Quality Business & Management Clinical Research
(Choose 2)
Introductory Regulation
Drugs & Biologics
Medical Devices
Quality
(Choose 1)
Systems & Standards
Business & Management
Biomedical Commerce
Managing Complex Projects
Managing Organizations & Human Resources
Clinical Research
Structure & Management of Clinical Trails

15. What Makes our Program Unique?
All faculty/mentors have 20+ years of industry experience and are still involved in industry
Being in the same courses as senior industry executives and guest speakers who are subject matter experts
Strong relationships with industry to help students get jobs
Courses held on the weekends and meet about every three weeks

16. Getting Started Complete an application usc.liaisoncas.com Resume/CV
Personal Statement
Letters of Recommendation (2)
Transcripts

17. Use Your Tuition Benefit
Staff
employees.usc.edu
Tuition Assistance Form
Graduate Coursework Certification Form
Postdoc
postdocs.usc.edu
Tuition Remission Form
Individual Development Plan (IDP)

18. Q&A