Director, Global Regulatory Affairs, Neuroscience Job at BioLife Plasma Services (Boston)

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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 (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

Job Responsibility

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
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

Requirements

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
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

What we offer

short-term and/or long-term incentives
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 per calendar year
new hires are eligible to accrue up to 120 hours of paid vacation

BioLife Plasma Services - All Job Offers

Select Country

Director, Global Regulatory Affairs, Neuroscience

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Director, Global Regulatory Affairs, Neuroscience

Accountant

Critical Environment Technician Manager

Psychologist/Psychological Assessment and Evaluation

Temporary Lettings Administrator

Senior Quantity Surveyor

Billing Specialist

Licensed Counselor/Social Worker/Psychologist

Lead Quantity Surveyor

Our AI answers in your language