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Products & Services Quality, Compliance and Regulatory Regulatory Affairs

Skills, Capabilities and Competencies for Success in Regulatory Affairs

ID: 5029


Features:

3 Info Graphics

7 Data Graphics

60 Metrics

7 Best Practices


Pages/Slides: 16


Published: Pre-2014


Delivery Format: Online PDF Document


 

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Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Skills, Capabilities and Competencies for Success in Regulatory Affairs"

STUDY OVERVIEW

The pharmaceutical industry uses Regulatory Affairs as its main communicator with the FDA. The success of a Regulatory Affairs group starts with hiring the right people. That’s not an easy task since a Regulatory Affairs professional requires an array of capabilities, from an understanding of basic science to possession of nimble negotiation skills. This study examines what is the most desirable skill set for a new Regulatory Affairs employee and the benefits/drawbacks of hiring former FDA officials. Regulatory leaders can use the insights from this research to compare their group’s skill sets and to consider whether to hire former FDAers.

KEY TOPICS

  • Executive Summary
  • Skill Sets
  • Science versus Regulatory Experience
  • FDA Experience
  • Performance Measurement

KEY METRICS
  • Top Methods for Working with the FDA
  • Characteristics Most Important for Staff Working with FDA
  • Ranking of Top Three Characteristics for Staff Working with FDA
  • Backgrounds that Prove Most Effective for Interacting with FDA Reviewers
  • Ranking of Top Three Backgrounds for Interacting with FDA Reviewers
  • Number of Staff with Prior Work Experience at FDA

SAMPLE KEY FINDINGS
  • Integrate multiple backgrounds and skill sets into Regulatory’s talent pool in order to build deep scientific, procedural, and agency knowledge.
  • Selective hiring of well-connected FDA staffers helps seed insight, expertise and understanding of how the agency runs.

METHODOLOGY
The research employed a data gathering approach that gleaned quantitative data from 15 biopharma companies and one medical device company through a detailed survey. In addition, 13 Regulatory leaders participated in in-depth interviews.

Industries Profiled:
Pharmaceutical; Biotech; Medical Device; Chemical; Manufacturing; Consumer Products; Diagnostic; Health Care


Companies Profiled:
Alcon; Medtronic; Lilly; Genentech; Bayer; Amgen; Roche; Novartis; Valeant; United Therapeutics; Bristol-Myers Squibb; Solvay Pharmaceuticals; AstraZeneca; Boehringer Ingelheim; Merck

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.