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

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
• Responsible for actively contributing to the development & implementation of CMC regulatory strategy for small molecule products in development 
• Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers  
• Coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or program
• Serve as the regulatory CMC representative on relevant project teams, & as the regulatory CMC contact with FDA
• Key internal leader and driver of regulatory policy and strategy
• Influence the development of regulations and guidance
• Provide executive management with meaningful regulatory measurements and regulatory opinion
• Partner with outside regulatory agencies and trade associations 
• Work under consultative direction to obtain long-range goals and objectives
• Provide direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; may be asked to evaluate performance of and assist in career development planning for subordinates
• Advance the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects
• Advise management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards, and on advisory committee recommendations
• Advise internal personnel on regulatory strategies
• Develop, communicate, and build consensus for operating goals that are in alignment with the division

REQUIREMENTS
• Bachelor’s degree in a scientific or technical discipline; advanced degree preferred 
• Must have a minimum of 10+ years experience in Regulatory Affairs
• Experience in leading CMC submission teams for clinical trial applications including leading CMC pre-IND, pre-NDA, IND, or NDA meetings with the FDA
• Management experience is a plus
• Must have strong strategy background
• Must have very strong technical skills in regulatory CMC
• Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements
• Knowledge of EU, Canada, ROW and Post-marketing a plus
• Direct experience in interacting with regulatory authorities
• Candidates must be able to influence others & demonstrate strong project management, problem-solving, negotiating, interpersonal & communication skills (both written and oral).

COMPENSATION
• Base $165,000 - $185,000+
• Bonus 
• Restricted Stock Units
• Pension plan
• Relocation
• Benefits