Associate Director/Director, Global Regulatory Affairs Development

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Job Description

Associate Director/Director Global Regulatory Affairs – Global Regulatory Lead – Rare Genetics and Hematology - Cambridge, Massachusetts or Zurich, Switzerland

The Associate Director/Director Global Regulatory Affairs, Rare Genetics and Hematology, is responsible for providing strategic regulatory guidance in the global development of rare diseases leading the Global Regulatory Team(s) (GRTs) in the development and implementation of regulatory strategies and operational plans to achieve marketing approvals in all major markets.  Represents the global regulatory function at Global Product Teams (GPT) and at the Therapeutic Area Unit (TAU) as required. 

OBJECTIVES:

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic regulatory advice on the clinical development of gene therapy products, including interpretation of final and draft regulatory guidance regarding manufacturing considerations, specific disease therapeutic targets (e.g., neurodegenerative diseases), and sameness of gene therapy products under the orphan drug regulations
• Keeps abreast of new developments in rare diseases development maintaining oversight on the rapidly evolving regulatory landscape and advancing innovations in the development of rare disease, products.
• 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.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Represents Takeda as applicable in industry/regulatory forums to lead regulatory innovation.

ACCOUNTABILITIES:

• The Associate Director/Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs 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.
• 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 responsible.  The Associate Director/Director will lead all submission types.
• Direct point of contact with health authorities, 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 or leads departmental and cross-functional taskforces
•  and initiatives.
• Serves as 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:

• Understanding of the regulatory framework for the clinical development and manufacturing of gene therapy products leading to global marketing authorizations.  Ability to advice on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
• Keeps abreast of new developments in gene therapy and maintains oversight on the rapidly evolving regulatory landscape and advancing innovations in the development of gene therapy products.
• 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. 
• Able to bring working teams together for common objectives.
• 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.

EEO Statement

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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