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

Therapeutic Area Head Regulatory Affairs


COMPANY
Our client is a multi-billion dollar biopharmaceutical company focused on innovative medicines for the treatment of cancer with over a dozen drug candidates in the pipeline.

LOCATION
Cambridge, MA

DESCRIPTION
• Provides global regulatory oversight for assigned therapeutic area (s), focused on non-clinical and clinical aspects of drug development and associated regulations. 
• Provides senior leadership, mentorship and training within regulatory organization; manages staff of multiple levels in different countries. 
• Provides direction to senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas of responsibility enabling proactive approach and planning to future business requirements
• Represent company’s regulatory affairs strategic interests on key internal and external committees 
• Collaborates with all regions on global regulatory strategies within therapeutic areas of responsibility
• Responsible for global regulatory development plans/strategies for all projects in TA scope (consolidated across JPN, US, EU and ROW) including ensuring clinical trial requirements for global product approval are met.
• Primary liaison person between GRA and TA Head
• Oversees and accountable for all US FDA submissions and approvals within therapeutic areas of responsibility. 
• Oversees and accountable for ensuring all other regulatory submissions within the non-US territories are submitted on schedule within therapeutic areas of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy. 
• In collaboration with regional RA liaisons, work to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables to territories outside the US as agreed within the global regulatory strategy.
• Supervises multiple direct reports and levels and provides oversight for staff day-to-day activities.
• Takes lead in critical health authority negotiations in key meetings or correspondence and in the design of strategies to resolve them with most optimal outcomes.
• Provides oversight of staff and approves regulatory components of licensing opportunity evaluations and recommendations
• Manages personnel and budget within group and therapy area(s) to cover overall responsibilities; Elevates needs when needed.
• Presents and informs senior management on regulatory strategies and key issues.
Identifies regulatory requirements and trends across therapeutic areas of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas. 

REQUIREMENTS
• A minimum of 15 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 15 years regulatory and/or related experience. 
• BSc. Advanced scientific related degree preferred; BA accepted based on experience. 
• Significant pharmaceutical industry experience. This is inclusive of considerable regulatory experience or combination of extensive regulatory and/or related experience. 
• Preferred experience across broad therapy areas and submissions experience; involved in global regulatory strategies; has led regulatory or cross functional teams. 
• Understands and can interpret complex and broad scientific issues as it relates to current and future global policy and regulatory decision making.
• Preferred experience in managing multiple personnel for multiple years
• Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Generally strong in working well with others, within teams and working with senior leadership
• Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 20% travel.









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