Regulatory Affairs: Department Models and Structures
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The report examines regulatory affairs functions within the top 50 pharmaceutical companies, based on interviews with 13 industry experts. It aims to serve as a benchmarking tool, highlighting differences in departmental structures, employee qualities, and best practices, along with challenges faced by regulatory affairs teams. Key insights include the importance of communication skills, strategic thinking, and the varying departmental structures that impact budget and operations.
Regulatory Affairs: Department Models and Structures
- 1. REGULATORY AFFAIRS: DEPARTMENT MODELS AND STRUCTURES M A R C H , 2 0 1 6 P R E V I E W O F REGULATORY AFFAIRS
- 2. REPORT OVERVIEW WHAT YOU WILL LEARN How you can use this report ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include: • Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result • Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function • Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies 56 PAGES 18 POTENTIAL BEST PRACTICES CAPTURED INTERVIEWEE TITLES MAJOR SECTIONS: 1. Introduction 2. Regulatory Affairs Employees 3. Regulatory Affairs Goals 4. Role of Regulatory Affairs Throughout the Lifecycle of a Medication 5. Regulatory Affairs Structure 6. Division of Work 7. Organizational Alignment 8. Outsourcing Behavior 9. Regulatory Affairs Budget 10. Department Challenges 11. Future Predictions 12. Best Practices and Recommendations • Regulatory Affairs department role, operations, and structure, including: • Division of work within the Regulatory Affairs sub-departments and the employee attributes that contribute to success • How different Regulatory Affairs departments are structured, why different structures are utilized and best practices to apply at your organization • Outsourcing behavior: reasons for outsourcing and vendor selection • Future predictions for the department • The components that impact the size of the Regulatory Affairs budget, estimates, and influencing factors to budget changes • Regulatory Affairs department challenges, such as global complexity, staff resources, and changing requirements • Best Practices for new hires, involvement timelines, work challenges and proposed solutions, department structure, and outsourcing behavior • Understand how your company’s approach to Regulatory Affairs may be different from a typical industry approach and use the information to improve the function • Compare the size of the department, the structure, division of work and resources to the Regulatory Affairs function at other Top 50 pharmaceutical companies • Learn the Best Practices that have contributed to Regulatory Affairs departments success’ and adopt best practices that may improve your company’s Regulatory Affairs deparment Introduction SMARTER QUESTIONS SMARTER ANSWERS • Associate Director, Regulatory Affairs • Associate Director Regulatory Affairs, Advertising and Promotion • Director, Global Regulatory Affairs • Director, Regulatory CMC • Regulatory Affairs Manager • Senior Director, Asset Team Leader Regulatory Affairs • Senior Director of Regulatory Affairs • Senior Director, Regulatory Affairs, Emerging Markets • Senior Director, Regulatory Operations • Senior Program Director, Regulatory Affairs • Senior Vice President, Regulatory Affairs • Vice President, Regulatory Affairs Asia-Pacific • Vice President, Regulatory Operations D A T A C O L L E C T I O N I N Q 3 , 2 0 1 5 6 0 - M I N U T E T E L E P H O N E I N T E R V I E W S 1 3 E X P E R I E N C E D R E G U L A T O R Y A F F A I R S P R O F E S S I O N A L S
- 3. Introduction SMARTER QUESTIONS SMARTER ANSWERS TABLE OF CONTENTS For full table of contents, sample pages, and ordering information, please download the full preview at: https://goo.gl/o9lTif
- 4. Introduction SMARTER QUESTIONS SMARTER ANSWERS UNDERSTANDING THE REGULATORY AFFAIRS FUNCTION Regulatory Affairs: Department Models and Structures 11www.ISRreports.com ©2016 Employee Qualities SCIENTIFIC KNOWLEDGE EXPERT KNOWLEDGE COMMUNICATE AGILITY STRATEGIC THINKING PERSEVERE FORWARD THINKING NEGOTIATE HARDWORKING Since Regulatory Affairs professionals are involved in product development from the earliest stages through post-marketing, the qualities of the employees must span a broad range of scientific information—from understanding molecule production to clinical knowledge� A Regulatory Affairs employee must be able to speak scientifically, pick up new information quickly, have a deep understanding of product development, be able to interpret and explain regulatory guidelines, challenge the status quo, assess risk, and apply risk assessment to the regulatory strategy� This requires good planning, time management, and attention to detail� As the primary liaisons between a biopharmaceutical company and the regulatory bodies, the ability to communicate—both in writing and verbally—is at the core of a strong Regulatory Affairs employee� Further, interpersonal skills such as questioning and listening, problem solving, and the ability to synthesize and simplify complex data skills are key� Perhaps the most common theme from respondents was that regulatory personnel must have strong negotiating skills and perseverance in order to put all of their other qualities into action� REGULATORY AFFAIRS EMPLOYEES “Quite difficult to attract the right talent�” Top 50 Pharma S A M P L E P A G E : REGULATORY AFFAIRS EMPLOYEE QUALITIES Communication is considered one of the core skills required for success in Regulatory Affairs. The role requires written and verbal communication between a biopharmaceutical company and the regulatory bodies. Employees must be able to speak scientifically and be able to interpret and explain regulatory guidelines and strategy. C L O S E R L O O K >>This chart shows a number of qualities that are necessary to be successful in the Regulatory Affairs role. UNDERSTANDING THE REGULATORY AFFAIRS FUNCTION Employee Qualities SCIENTIFIC KNOWLEDGE EXPERT KNOWLEDGE COMMUNICATE AGILITY STRATEGIC THINKING PERSEVERE FORWARD THINKING NEGOTIATE HARDWORKING Since Regulatory Affairs professionals are involved in product REGULATORY AFFAIRS EMPLOYEES
- 5. Introduction SMARTER QUESTIONS SMARTER ANSWERS Introduction REGULATORY AFFARIS DEPARTMENT BENCHMARKING Regulatory Affairs: Department Models and Structures 23www.ISRreports.com ©2016 Regulatory Affairs Structure According to research participants, Regulatory Affairs departments vary considerably in size and structure from business to business� In this section, ISR will illustrate typical structures for a Regulatory Affairs department at Top 50 pharma companies and call out some reported benefits and/or drawbacks to the different structures as described by interviewees� As detailed below, there are a variety of ways to structure a Regulatory Affairs department� The first scenario proved to be the most common among research participants and was the reported structure for multiple Top 10 and Top 25 companies as well as a Top 50 pharma company with small variations� The most common variation on this structure is the presence of a sixth sub-department—illustrated below as a “specialty department” within the Regulatory Affairs group� The additional specialty department varies in focus from company to company� Regardless of the department’s structure, several sub-departments were consistently mentioned by research participants: CMC, Labeling, and Regulatory Ops� Sometimes sub-department names seemed to be unique to the interviewee’s company but fulfilled a purpose that was common to multiple organizations� Common Regulatory Affairs Global Structures REGULATORY AFFAIRS CMC STRATEGY STRATEGY OPERATIONS LABELING AD/PROMO SPECIALTY DEPARTMENT SCENARIO 1 REGULATORY AFFAIRS REGIONAL HEAD THERAPEUTIC AREA HEAD CMC LABELING PUBLISHING LOCAL AFFILIATE LOCAL AFFILIATE COUNTRY MANAGER SCENARIO 2 S A M P L E P A G E : REGULATORY AFFAIRS STRUCTURE ISR interviewed 13 highly experienced decision-makers in the Regulatory Affairs function to gain insight from this report. In this section, ISR illustrates 5 typical structures for a Regulatory Affairs department at Top 50 pharma companies and calls out some reported benefits and/or drawbacks to the different structures as described by interviewees.
- 6. Introduction SMARTER QUESTIONS SMARTER ANSWERS For full table of contents, sample pages, and ordering information, please download the full preview at: https://goo.gl/o9lTif
- 7. Introduction SMARTER QUESTIONS SMARTER ANSWERS ORDERING INFORMATION Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise. For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. ABOUT INDUSTRY STANDARD RESEARCH >> R E G I S T E R N O W >>Receive $250 instant credit towards any ISR report >>Earn 10% credit towards all future purchases >>Receive advanced notifications on ISR’s latest reports and free resources SAVE ON THIS, OR ANY ISR REPORT, BY CREATING A FREE ACCOUNT For full table of contents, sample pages, and ordering information, please download the full preview at: https://goo.gl/o9lTif
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