TakedaPharmaceutical Nordics AB · 8 hours ago
Director, Global Regulatory Affairs, Neuroscience
Boston, MA
Full-time
Hybrid
Director/Executive
$174K/yr - $274K/yr
10+ years expTakedaPharmaceutical Nordics AB is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit portfolio.
Pharmaceuticals
Responsibilities
Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects
Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations
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
Participates in cross-functional initiatives within Global Regulatory Affairs and Takeda R&D
The Director will be responsible for increasingly complex or multiple projects
Leads the Global Regulatory Team (GRT) and applicable sub-working groups 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
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 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
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
Qualification
Required
BSc Degree, preferred. BA accepted
10+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience
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
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
Preferred
Preferred experience in reviewing, authoring, or managing components of regulatory submissions
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase