Executive Director, US Regulatory Affairs
Posted on Apr 5, 2021 by BeiGene, Ltd.
The Executive Director, US Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. Equally important to this role is the development and growth of a team of regulatory affairs professionals capable of managing all aspects of the regulatory process from initial health authority interaction to post-marketing and lifecycle management. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners in regard to development, regulatory, and registration strategies. They will attract top talent to the US Regulatory team and build a comprehensive and skilled team capable of meeting and exceeding corporate goals. They will provide line management, people development, and performance management as well as support/lead development and implementation of departmental policies.
Essential Functions of the job:
Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
Provides supervisory management and development of regulatory staff across a product's lifecycle. Builds and strengthens their regulatory team. Increases team efficiency and capability through management and education. Ensures that the regulatory team builds and maintains excellent cross-functional relationships throughout the organization.
Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
Reviews sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.
Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.
Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
Manages critical issues, taking leadership for the regulatory contribution Responsible for assisting with the development and implementation of regulatory processes
Recruits, develops, manages and mentors regulatory professionals and helps sustain BeiGene's mission and culture.
A minimum of 15 years in the biotechnology or pharmaceutical industry and a minimum 10 years in a Regulatory leadership capacity with a broad background in hematologic malignancies. Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, prior experience with both small molecules and biologics, and experience leading multiple FDA interactions leading to Agency approval actions. Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.
Thorough understanding of drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
Strong business acumen and ability to integrate multiple sources of data to make sound decisions that contribute positively to the business
Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Extensive supervisory responsibilities for multi-level regulatory team(s), with opportunity to grow the supervised organizational structure.
Education Required: Bachelor's degree required; advanced degree preferred
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyones efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Extensive experience with Microsoft Office suite; Veeva regulatory publishing; expertise with PowerPoint presentation authoring and presentation.
Business travel to be 10-20% as required; negotiable.