Director, Global Regulatory Affairs Labeling Lead
Posted on Apr 5, 2021 by Takeda Pharmaceuticals
Responsible for operational oversight and leadership for Takeda Global Labeling (GL), including labeling vendors assigned to GL responsibilities and tasks.
Develops, implements, and oversees appropriate systems to ensure compliance with external regulatory labeling requirements and internal Takeda standards.
Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.
Provides leadership and development for direct reports, including those that serve as global labeling leads responsible for the design and execution of global labeling strategies in collaboration with their regional counterparts.
Plans and manages CCDS (creation, maintenance, distribution, tracking and implementation), US, and EU labeling processes in line with strategic priorities and compliance with government regulations/Takeda quality standards to ensure commercial product integrity
Establishes and manages relationships with labeling vendors to ensure the effective implementation of labeling processes to meet business needs and regulatory requirements.
Monitors Local Operating Company (LOC) compliance with labeling activities, takes corrective actions as needed
Manages preparation of the Pharmacovigilance Site Master File (PSMF) labeling sections, and inspection/audit activities
Participates with influence in or leads departmental and cross-functional task-forces and initiatives
Identifies risks with mitigation plans and communicates with GL Head
Serves as a labeling resource to the Therapeutic Area Units, Marketed Products, and US/EU Labeling Operations as well as Local Operating Companies for labeling issues
Leads the development of new strategic and operational initiatives to improve the efficiency of Global Labeling, US and EU labeling operations
Monitors industry labeling trends and proposes actions as appropriate
Provides leadership to GL staff (including Takeda employees, vendors, and partners) in establishing roles/responsibilities and accountabilities across the labeling function(s).
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BSc Degree, preferred. BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred
10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.
Understanding of scientific principles and regulatory/quality systems relevant to drug development.
Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
Must work well with others and within global teams.
Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies.
Responsible for demonstrating Takeda leadership behaviors.
Manual dexterity required to operate office equipment (ie computers, phones, etc.).
Carrying, handling and reaching for objects.
Ability to sit or stand for long periods of time while traveling.
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 10-30% travel.