Career Options Series: Regulatory Affairs

April 13, 2016

OITE’s Career Options Series will give you a snapshot overview of different career paths. The goal of this series is to help you explore a variety of different options by connecting you to new resources.  A large part of making a good career decision is done by gathering information about that field.  We encourage you to follow up this online research by conducting informational interviews with individuals in each field. Search the NIH Alumni Database to find alums doing similar work.


What is Regulatory Affairs?Image of the words "Regulatory Affairs" with two figures holding a puzzle piece
A profession that functions to apply laws, regulations, and policies to the development, production, and sale of products within regulated industries, such as: food, pharmaceuticals, medical devices, energy, biotech, clinical, and health care products. Why is it needed? To make sure company businesses/products abide by applicable regulations, laws, and guidelines in every country where a product will be marketed.

Regulatory affairs requires expertise from multiple disciplines, such as: research science, physicists, life scientists, chemists, engineers, pharmacy, statistics, veterinary medicine, nursing, clinical medicine, etc.

Sample Job Titles
Regulatory Affairs Specialist, Regulatory and Quality Affairs Analyst,  Policy Manger, Scientist, Regulatory Affairs Associate, etc.

Sample Work Settings/Employers
Regulatory Affairs in the Federal Government:|
FDA
– FDA scientists review test results submitted by sponsors, so that the FDA can decide whether the drug is safe enough for clinical trials, whether the drug can be sold to the public, and what should go on the drug’s professional labeling.
USDA – Inspect food safety, and collect and analyze surveillance data of foodborne outbreak; conduct studies such as evaluations, like Child Nutrition Studies or Food Security Studies in response to the needs of policy makers and managers.
EPA –  Assess exposure, hazard and risk of chemical substances and/or toxic substances; assess risk of environmental pollutants, and develop biological indicators.

Regulatory Affairs in the Private Sector:
Industry – Gather data necessary for submission to government. Manage process of regulatory approval

Consulting/Regulatory Affairs Services – Provide evaluation of the best regulatory path. May provide outsources submissions and follow-up services.

Key Skills
– RA needs individuals with backgrounds in biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences, writing and management
– Knowledge of science, regulations, and policy
– Verbal  and written communication skills
– Analytical and organizational skills, including the ability to evaluate potential product candidates and trials
– Project and time management skills
– Computer skills
– People skills, including the ability to mediate and find common ground among interested parties (research, production, sales, marketing, regulatory agencies, etc.) and gain consensus

How to get started
• Commissioner’s Fellowship Program (FDA)
• CDER Academic Collaboration Program (FDA)
• CATO Fellowship
• Trainings:
– The Regulatory Affairs Professional Society (RAPS) Online University
– NIH FAES Graduate School Classes (Look at current availability but previous relevant classes have     included Inside and Outside the FDA or FDA Regulation, Industry and Hidden IP)
– Master’s of Science in Regulatory Affairs programs
• Regulatory Affairs Branch (RAB), NIH, NCI

Professional Organizations
The Regulatory Affairs Professional Society (RAPS)
The Organization for Professional in Regulatory Affairs (TOPRA)
The Canadian Association of Professional Regulatory Affairs (CAPRA)

Additional Resources
OITE’s How To Series: Regulatory Affairs, including an archived video, slides, and more resources!

 

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Coming up in the Career Options Series, we want to know what you which work path you would like to see highlighted. Take a moment to vote below:

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Career Options Series: Public Health

November 9, 2015

OITE’s new Career Options Series will give you a snapshot overview of different career paths. The goal of this blog series is to help you explore a variety of different options by connecting you to new resources. A large part of making a good career decision is done by gathering information about that field. We encourage you to follow up this online research by conducting informational interviews with individuals in each field.


What is Public Health?
Image of a large globe with hands from different indiviudals touching it
“Public Health is the science of protecting and improving the health of communities through education, promotion of healthy lifestyles, and research for disease and injury prevention. Public health professionals analyze the effect on health of genetics, personal choice and the environment in order to develop programs that protect the health of your family and community.”
– From the resource: http://www.whatispublichealth.org

Sample Job Titles
Global Health Specialist; Public Health Analyst; Field Support Manager; Public Health Director; Health Policy Analyst; Regional HIV/AIDS Technical Advisor; Program Associate; Program Officer for Africa, East Asia, etc; Health Policy Consultant; Nutrition/Sanitation/ Maternal Health Specialist; Proposal Writer; Health Coordinator; Field Organizer; Project Manager; Advocacy Officer; Consultant; Program Analyst; Public Health Associate; Regional Specialist, and many more.

Sample Work Settings
Government Agencies; Government Contractors; Intergovernmental or Multi-Lateral Agencies; Non-governmental (NGO) agencies or Non-Profits; Private Sector such as consulting firms or lending agencies; Think Tanks; In-Country/Disaster Relief

Sample Employers
Abt Associates
ACDI/VOCA
Advocates for Youth
American Red Cross
Bill and Melinda Gates Foundation
CDC
Devex
Department of State
Doctors of the World
EngenderHealth
Family Health International
Human Rights Watch
ICF International
Kaiser Foundation
NIH
Peace Corps
Public Health Institute
United Nations
UNESCO
UNFPA
UNICEF
USAID
World Health Organization
World Vision

Potential Topics/Areas of Specialty
• Biostatistics and Informatics
• Community Health
• Capacity building
• Communicable Diseases
• Consulting
• Emerging economies
• Environmental Health
• Epidemiology
• Global Health
• Grants management
• Health Administration
• HIV/AIDS
• Infectious diseases
• Migration & Quarantine
• Neglected diseases
• Program evaluation
• Policy
• Reproductive health
• Social and Behavioral Health
• Vaccines
• Vulnerable Populations
• Water, Sanitation & Hygiene

Key Skills
– Communication, both written and verbal
– Language Skills — proficiency in Spanish, French, Arabic, Chinese, etc
– Analysis and Evaluation
– Project/Time Management
– People skills (consensus building)
– Cultural Sensitivity
– Problem-Solving

How to get started
Fellowships e.g., USAID Global Health Fellowship
Internships e.g., NCI Health Communications Internship
Details e.g., NIH institutes; 1 day/week
Networking e.g., With speakers at NIH global health seminars
Volunteering e.g., Global Health charities, here and abroad
Additional education/degrees (Masters in Public Health)
Certificates (Certificate in Public Health –FAES)

Professional Organizations
American Public Health Association
Global Health Council
WFPHA

Additional Resources
OITE’s How To Series: Global Health
Guide to Public Health Careers
Explore Public Health Careers
Schools of Public Health Application Service

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Coming up in the Career Options Series, we will be highlighting the field of Science Policy.