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Explore the expanding strategic role of regulatory professionals including the need for critical thinking, leadership skills, professional development strategies, the importance of professional qualifications and techniques for transitioning between roles.

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The regulatory profession has experienced an exciting evolution over the past few decades. Explore the changing and ever-increasing roles available today and the importance and stature of the regulatory professional as a key strategic player in global organizations.

Books

Choosing the Right Regulatory Career (Paperback)
Promotion of FDA-Regulated Medical Products (Hardcover)

Sponsored Webcasts

AI for Postmarket Surveillance Compliance and Regulatory Work According to MDR (5 February 2020)
EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe (12 February 2020)
Strategic Role of the RA Professional (26 February 2020)

On-Demand Webcasts

Steps to a Successful Advisory Committee Meeting
A Roadmap for Driving Messages Through Development, Submission and Beyond
How to Facilitate Regulatory Meetings

Online Courses

Regulatory Due Diligence for Product Development

Articles

RF Series: Regulatory Management and Leadership Strategies, Vol. 2, No. 3, 2019 (member exclusive)
Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement 11 December 2020 (member exclusive)
The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues 16 March 2017
RAPS and the Regulatory Profession: The Future of Regulatory 7 September 2016
RAPS and the Regulatory Profession: How Far We Have Come 20 July 2016

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The “what” communicated in regulatory is important to conveying messages, but how the message is communicated is even more crucial to ensuring stakeholder understanding and influencing the dialogue and decision-making. Create, plan and deliver content that heightens the relevance of your regulatory message.

Books

Regulatory Writing: An Overview  
Communication and Negotiation (Paperback)

On-Demand Webcasts

Argumentation and Persuasion for Regulatory Professionals
How to Effectively Talk to Regulators
Negotiation is Another Word for Problem Solving

Online Courses

Introductory Medical Writing
Effective Regulatory Communication

Articles

Curiosity. One of Life’s Most Valuable Commodities 9 July 2019
RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators 22 August 2016
8 Pieces of Advice for New Regulatory Professionals 9 June 2016
Handling Regulatory Challenges: Responding With Grace Under Pressure 26 January 2016

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Increasingly complex products, corporate structures and regulatory environments have created a demand for highly skilled regulatory leaders. Explore various skillsets required for a successful regulatory professional career.

On-Demand Webcasts

Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program
Giving Voice to Regulatory Leadership

Online Courses

Ethics – Essential Tools for Regulatory Professionals

Articles

Regulatory Leadership for a Culture of Quality 21 January 2020 (member exclusive)
Critical Thinking and Leadership Skills for Regulatory Professionals 1 August 2019 (member exclusive)
Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants 16 May 2018
Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program 8 March 2018 
RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification 21 July 2016
How to be a Regulatory Leader 20 May 2015
An Individual’s Experience at the RAPS Executive Development Program 14 May 2015
J&J’s Regulatory Executives Groomed as Business Leaders 9 December 2014

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The regulatory field offers many possibilities for horizontal career changes in addition to advancement opportunities. Discover ways to move between different areas of focus and up the corporate ladder.

On-Demand Webcasts

Giving Voice to Regulatory Leadership
Ask a RAPS Fellow: Industry Leaders Share Their Insight on the Profession

Online Courses

Role of the Regulatory Professional
Introduction to Regulatory Affairs in the U.S. and Canada
Introduction to Regulatory Affairs in the EU
Medical Devices: Definition & Lifecycle
Pharmaceuticals: Definition & Lifecycle
Project Management for Regulatory Professionals

Articles

Regulatory Affairs Consultants. Who needs them and why? 24 January 2020 (member exclusive)
Consultants: How to Hire and Engage for Success 7 January 2020 (member exclusive)
Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization 21 August 2019 (member exclusive)
Professional Development: Benefits of Obtaining Professional Qualifications 7 August 2019 (member exclusive)
How I Returned to Regulatory Affairs After a 10-Year Break 9 April 2019
Making the Switch to Advertising and Promotion: My First 90 Days 18 October 2018
Why Regulatory Professionals Need Business Training 1 March 2018
What Can Employers Do to Attract and Retain Top Regulatory Talent? 8 August 2014
Business Skills Crucial to Regulatory Professionals’ Success 15 August 2013
2018 Compensation and Scope of Practice Report