Takeda Pharmaceuticals Director/Associate Director, Global Regulatory Affairs – Neuroscience (Hybrid) in Boston, Massachusetts
Defines, develops and leads global strategies to maximize regulatory success towards achievement of program objectives for complex and/or multiple projects.
Provides strategic and tactical advice to cross-functional teams focused on late-stage as well as early-stage clinical programs in order to achieve project team goals, while ensuring compliance with applicable regulatory requirements.
Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
Responsible for increasingly complex or multiple projects. Is a member of the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
Defines strategy for preparation of briefing packages for regulatory agency meetings, and works collaboratively with cross-functional team members to prepare and review content.
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director/Director will lead highly complex submission types such as original NDA/BLAs.
Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
Contributes to and/or leads submissions made to Health Authorities outside the US.
Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in departmental and cross-functional task forces and initiatives.
Lead regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Responsible for demonstrating Takeda leadership behaviors
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
Employees - 0-5
Non-Employees - 0-3
Employees - 0-5
Non-Employees - 0-10
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BSc Degree, preferred. BA accepted.
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience.
Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Must work well with others and within global teams.
Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- None required.
Manual dexterity required to operate office equipment (i.e. 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.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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