Executive Director, Regulatory Affairs

Role Overview

• Leads the Regulatory CMC team responsible for our company's antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
• Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs.
• Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
• Ensures appropriate reviews, approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities.
• Provides critical review of major submission documents and response to Health Authority questions.
• Effectively communicates CMC regulatory strategy, risk, mitigation and overall plan to the GRACS, R&D, Manufacturing, GHH management team, product development teams, and executive management, as relevant.
• Establishes strong cross-functional and divisional partnerships to ensure collaboration with key stakeholders, customers and external organizations.
• Negotiates with and influences the opinions of others within and across the divisions and regulatory agencies.
• Represent GRACS CMC on key executive level meetings and leadership forums, as a delegate for the CMC Leadership Team member, as required.
• Actively engage as a Leadership Team member within the regulatory CMC department.
• Monitors changes in regulatory environment with potential strategic impact working closely with Regulatory CMC Policy.
• Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues.
• Evaluates key business challenges for products/programs within the biologics portfolio and collaborates with team members to direct the development of new and improved solutions.
• Develops plans to execute functional and divisional strategies and initiatives.
• Applies appropriate combination of perspectives (business, technical, global, etc.) when making decisions and generating solutions.
• Develops resource requirements and directs the allocation of the resources to meet regulatory CMC deliverables for the team.
• Works with R&D, Manufacturing, and GHH to prioritize work within the assigned biologics products to ensure effective support for the portfolio.
• Partners with R&D, Manufacturing, and GHH to ensure robust prioritization of work to meet agreed upon goals across the organization.
• Influences and drives development of innovative solutions to problems and ability to make rapid, disciplined decisions across divisions.
• Manage, coach, and develop CMC staff including performance management and advancement of personal and professional development goals to ensure the team is highly capable of regulatory CMC deliverables required for the biologics portfolio and they are developing broad regulatory CMC capabilities.
• Identify key talent and provide development opportunities that enable growth and retain talent.

Requirements

• Minimum of (15) years experience in the Pharmaceutical Industry with direct experience in CMC relevant technical functions.
• Minimum of (10) years’ experience in Regulatory CMC with progressive experience in leading global programs from pre-approval or post-marketing.
• Direct experience in ADC highly preferred.
• Minimum of (7) years People Management/ Leadership experience with proven track record of developing talent.
• Leadership of larger groups is strongly preferred.
• Demonstrated ability to anticipate and influence within and across divisions/business units and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk.
• Recognized as a leader with broad expertise in CMC regulatory strategy and dossier management activities across product development, registration and life-cycle management.
• Present and influence key topics at Industry/Agency meetings and conferences.
• Experience leading organizational or process related change to drive effective execution and continuous improvement.
• Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.
• Flexibility to operate in a matrix-managed environment and to support staff in that same environment.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days