The Global Regulatory Labeling Expert is responsible for the labeling strategy development and risk assessment of activities in support of global prescribing information development, from early-phase to late-phase life-cycle management (Target Product Profile to Core Data Sheet). This person will integrate overall business objectives into departmental labeling goals by standardizing SOPs, processes, and best regulatory labeling best practices. This person oversees the regulatory strategy for developing core labeling documents across the various functions in the department and implementing the Label as a Driver approach. This role also acts as the Global Labeling Committee chair. This position influences regulatory agencies, professional organization and other teams within Biogen in matters related to global labeling.
Duties and Responsibilities:
A. Essential Functions:
Optimize the processes and procedures associated with the integration of regulatory strategy and tactics in the development of the company Target Product Label and the and the Company Core Data Sheet based on the Target Product Profile.
Establish innovative strategies for achieving regulatory compliance for global prescribing information.
Establish parameters for labeling and influence teams to share a common vision.
Strategically assess global prescribing information activities and enable cross-functional team decision making for these activities
Execute effective decision-making, planning and project management in the development and life cycle management of the Target Product Label and Company Core Data Sheet
Chair the Global Labeling Committee
Develop and maintain the Core Data Sheet and lead global labeling team meetings.
Prepare and deliver effective presentations for external and internal audience.
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
Mentor Regulatory Strategists and Medical Writers and provide guidance in carrying out responsibilities.
Provide input to Regulatory Senior Management teams.
Maintain a global view as part of the whole regulatory team.
B. Additional Functions:
Take steps to actively improve interdepartmental communications.
Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
May have presence on external regulatory committees/trade associations.
BA/BS/University degree required, ideally in the life/health sciences. Graduate degree preferred.
Ideal candidate will have a minimum of 8 years regulatory or relevant industry experience.
Experience in interpretation of labeling regulations.
Experience in interfacing with regulatory agencies and at external industry meetings.
Demonstrate excellent leadership, communication and influencing skills internally and externally at all levels of the organization.
Demonstrate effective cross functional and cross-cultural skills to effectively interact with global counterparts.
Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
Ability to build capability through coaching and mentoring.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Ability to represent the department in project teams, committees and external meetings.
Demonstrate strong organizational skills, including the ability to prioritize personal workload.
Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.
Well organized, detail oriented, effective written and oral communication skills.
Supervisory/mentoring experience. Ability to guide, train, supervise and prioritize workload of direct reports if applicable.
Some international regulatory experience preferred.
The Global Regulatory Labeling Expert is responsible for the labeling strategy development and risk assessment of activities in support of global prescribing information development, from early-phase to late-phase life-cycle management.
This person oversees the regulatory strategy for developing core labeling documents across the various functions in the department and implementing the Label as a Driver approach. This role also acts as the Global Labeling Committee chair.