The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Senior Director, Regulatory Affairs, Area & Affiliates US & Canada


COMPANY
Our client is a global research-based biopharmaceutical company that employs over 20,000 people in over 170 countries with more than $20B in revenue. They develop and market advanced therapies that address some of the world’s most complex and serious diseases.  

LOCATION
IL

DESCRIPTION
The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed, to meet required legislation. The individual has division and corporate level influence and is generally considered a key opinion leader and resource both within the company and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. The individual may direct the development of strategy and organizational structure to ensure product promotion, global registration of products, processes, and facilities and maintenance of products and processes in regulatory compliance. 
• Develop global regulatory strategies and update based upon regulatory changes 
Strategize regulatory due diligence for potential and new acquisitions and advise executive management
• Develop corporate positions on regulatory risk-benefit 
• Create and develop product positioning strategies based upon regulatory requirements 
Integrate regulatory considerations into the corporation’s global product entry and exit strategy
• Recruit, develop, manage and mentor regulatory professionals to contribute to organizational/human capital planning
• Provide strategic guidance for resource and development planning
• Negotiate with regulatory authorities during the development and review process to ensure submission approval
• Formulate company procedures to respond to regulatory authority queries  
• Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information 
• Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance 
• Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives 
• Interfaces with senior and executive management on significant matters, often requiring the coordination of activity across organizational units 
• Provides technical leadership at the division and/or corporate levels. 
• Creates mid- to long-range plans to carry out objectives established by top management
• Develops and calculates a budget for one or more departments to meet organizational goals

REQUIREMENTS
• Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
• M.S. in a technical area or M.B.A. is preferred
• A Ph.D. in a technical area or law is helpful
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 15+ years experience in a regulated industry (e.g., medical products, nutritionals)
• 10+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents, submission/registration types and requirements, as well as GxPs (GCPs, GLPs, GMPs) 
• Principles and requirements of promotion, advertising and labeling
• International treaties and regional, national, local and territorial trade requirements, agreements and considerations
• Domestic and international regulatory guidelines, policies and regulations
• Ethical guidelines of the regulatory profession, clinical research and regulatory process 
• Ability to direct and manage the preparation of technical strategic regulatory documentation for agency submission
• Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
• Demonstrated effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks 

COMPENSATION
• Base $220,000 - $230,000+
• Bonus 28%+
• Restricted Stock Units 
• Pension plan
• Relocation
• Benefits