Sr. Director, Regulatory Strategy

Job Description

The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered medicines, and/or (3) for the support of marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.

Key Duties and Responsibilities:

• Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications
• Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy
• Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices
• Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
• Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy.
• Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise
• Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
  
  

Knowledge and Skills:

• A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
• Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents
• Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
• Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments. Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals
• Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.
• Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.
• Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.
• Ability to articulate the organization’s strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs and initiatives.
• A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.
  
  

Education and Experience:

• Bachelor's degree in Biology, Chemistry, or other related discipline
• Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience
  
  

Job Identifier: #4855