Skills, Capabilities and Competencies for Success in Regulatory Affairs
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.
Business Operations > Facilities Services > Roles and Responsibilities
Industries Profiled:
Pharmaceutical; Biotech; Medical Device; Consumer Products; Diagnostic; Health Care
Companies Profiled:
Alcon; Medtronic; Lilly; Genentech; Bayer; Wyeth Pharmaceuticals; Amgen; Roche; Novartis; Valeant; United Therapeutics; Bristol-Myers Squibb; Solvay Pharmaceuticals; AstraZeneca; Boehringer Ingelheim; Merck
Special Offer: 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 J.B. Barrow at 919-767-9229 if you have any questions.
Other Research in:
Business Operations > Facilities Services > Roles and Responsibilities
Select items of interest and click the "Add Selected Items to Cart" button below.
|