Search Results for regulatory profession

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Regulatory Career Progression By Kamila Kawiak, Kavita Patel - Published 17 July 2017

This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.

Categories: Features, Business and Leadership, Career Development, Career Search

Tags: Career Development, Regulatory Profession

RAPS and the Regulatory Profession: The Future of Regulatory By Mary Meagher - Published 07 September 2016

Over the past 40 years, RAPS has sought to elevate the regulatory profession through education, certification and the sharing of knowledge. While RAPS members will celebrate this drive toward regulatory excellence in San Jose at the 2016 Regulatory Convergence, the regulatory environment continues to evolve.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: regulatory profession, future, RAPS 40th anniversary

RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators By Mary Meahger - Published 22 August 2016

When the regulatory profession convenes for the 2016 Regulatory Convergence in San Jose next month, it will be an occasion for members from both government and industry to build on their working relationships, to discuss with one another new guidelines and compliance issues and, generally, to bridge their understanding about regulatory matters unique to those who work in different facets of the profession.

Categories: HTML, Articles, Under RAPS, About the Profession, Communication

Tags: RAPS 40th Anniversary, regulatory profession, communication

RAPS' First Chapter Celebrates 25 Years By Mary Meagher - Published 27 July 2016

The RAPS Bay Area Chapter is RAPS’ first, and will celebrate its 25th anniversary as RAPS celebrates its 40th during the 2016 Regulatory Convergence in San Jose, CA. We look back at the chapter’s origins, and at its current state as one of RAPS’ largest, most active chapters.

Categories: HTML, Articles, Under RAPS, US, San Francisco Bay Area Chapter, About the Profession, Career Development

Tags: RAPS 40th Anniversary, regulatory profession, San Francisco, Bay Area, Chapter

RAPS and the Regulatory Profession: The Global Professional Network By Mary Meagher - Published 26 July 2016

Because regulatory issues are relatively unique—and a shared body of knowledge is important to regulatory professionals’ work—RAPS helps provide the continued education, skills and connections to address the challenges regulatory professionals face every day. RAPS provides the platforms for regulatory professionals to interact with one another, whether they work for regulatory agencies, in industry, academia or elsewhere. This shared professional network helps everyone better understand the issues that are evolving and how to engage in creating solutions.

Categories: HTML, Articles, Under RAPS, About the Profession

Tags: RAPS 40th Anniversary, regulatory profession

RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification By Mary Meagher - Published 21 July 2016

Forty years ago, RAPS was born as members of a burgeoning profession desired to keep abreast of regulatory developments in the medical device industry. As the scope of work of regulatory professionals has expanded, so too has RAPS’ mission to drive regulatory excellence for the profession, paving the way with training and certification.

Categories: HTML, Articles, Under RAPS, About the Profession

Tags: RAPS 40th Anniversary, regulatory profession

RAPS and the Regulatory Profession: How Far We Have Come By Mary Meagher - Published 20 July 2016

As RAPS  celebrates 40 years of driving regulatory excellence, it has seen its membership  transformed from a  collection of individuals from varied fields, tasked  with the administrative aspects of a growing body of regulatory requirements,  to a group of regulatory professionals who are asked to work throughout the  product lifecycle—who link science, technology and innovation with clinical  needs, and maintain a watchful eye on regulations, policy and good business  practice.

Categories: HTML, Articles, Under RAPS, About the Profession

Tags: RAPS 40th Anniversary, regulatory profession

Competency Expectations for the Regulatory Professional: A Changing Paradigm By Andrey Mladenov and Siegfried Schmitt - Published 21 August 2015

This article discusses the impact of recent industry developments and pharmaceutical market trends on the expertise and experience required for today's regulatory professionals.

Categories: Articles, Features, About the Profession, Career Development

Tags: competency, regulatory competency, regulatory profession, professional development

Be Curious and Be Professional, Says Medtronic China Regulatory Director Yin By Max Shen - Published 08 May 2015

Annie Yin, regulatory affairs director for Medtronic in China, and a faculty member for RAPS' Medical Device Regulatory Affairs Certificate Program in partnership with the National University of Singapore, shares her thoughts and analysis of the regulatory profession in China today.

Categories: HTML, Articles, Under RAPS, China, About the Profession

Tags: China, regulatory profession, Annie Yin

RAPS Scope of Practice Study: Tracking the Regulatory Profession Published 22 February 2012

RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the RAPS Global Scope of Practice & Compensation Survey. This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications.

Categories: Under RAPS

Tags: Sherry Keramidas, Scope of Practice, regulatory profession, study

The Regulatory Professional as Boundary Spanner By Ira Asherman - Published 01 November 2011

Today's regulatory professionals find themselves in an ever more complicated and challenging environment. Their core responsibility is to ensure their firm's compounds move through the approval and labeling process as rapidly as possible. The pressure to achieve this goal, among others, is constant and unrelenting, and the regulatory professional plays a central role in that process. He or she is the company's representative in dealing with the governing agency as well as the person who translates the agency's requirements and concerns back to his or her co-workers. Everyone is concerned with how effectively the regulatory professional interacts with the agency. It is a process that everyone is watching and on which everyone has an opinion. Like it or not, the regulatory professional has a very critical and demanding audience.

Tags: Quality and Compliance, negotiation, trust, regulatory profession, boundary