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 CMC Regulatory Affairs


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
• Have division and corporate level influence and is generally considered a key opinion leader and an expert resource both within the company and externally
• Influence changing regulations and guidance
• Interface with outside regulatory agencies and trade associations 
• Acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy
• 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
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures
• Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture
• Participate in developing/updating organizational code of ethics
• Develop global regulatory strategies and update based upon regulatory changes
• Strategize regulatory due diligence for potential and new acquisitions and advise executive management
• Sets quality and accuracy standards
• Develop solutions to address issues with other members of management and stakeholders
• 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
• Formulate company procedures to respond to regulatory authority queries
• Ensure annual licenses, registrations, listings and patent information are maintained
• Develop CMC regulatory strategies which maximize opportunity to receive first pass approval of regulatory submissions
• Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests
• Ensure a system is in place to manage access to information requests
• Individual may manage multiple groups and/or departments, approves organizational structure and supervisory relationships, and provides direction and guidance to exempt, non-exempt and/or supervisory personnel who exercise significant latitude and independence in their assignments
• Travel: 20 % of the Time

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.) 
• 10+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• 15+ years experience in a regulated industry (e.g., medical products, nutritionals).

COMPENSATION
• Base $200,000 - $230,000+
• Bonus 28%+
• Restricted stock units
• Pension plan
• Relocation
• Benefits