Director, Global Regulatory Affairs, Neuroscience

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Job Description

About the role:

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.

TheDirector Global Regulatory Affairs, Neuroscienceis responsible for developing innovative global regulatory strategies andproviding strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.This isaccomplished through leadership of product-specific Global Regulatory Teams (GRTs) andrepresenting the regulatory function on cross-functional Global Program Teams.   

• Defines,develops, and leads global strategies tomaximize globalregulatory successtowardsachievement ofprogramobjectives forcomplex and/or multiple projects. 

• Keepsabreast of newdevelopments inregulatory science andmaintainsoversight on theevolvingregulatorylandscape andadvancinginnovations. 

• Understands andinterpretsscientific dataasitrelates toregulatoryrequirements and strategyforassigned projects andprovides knowledge and expertise to guide team inestablished andbuilding appropriateregulatory strategy. 

• Participates in cross-functionalinitiativeswithin GlobalRegulatory Affairs and Takeda R&D.  

How you will contribute:

• The Director willbe responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groupsandrepresents 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 mayimpact regulatory success,exercising sound judgement and communicating in a professional andtimely manner. 

• Proactivelyanticipates risks and responsible for developing solutions toidentified 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 leadhighly 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, otherfunctions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and tomaintain compliance for products. 

• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. 

• Participates with influence in departmental and cross-functionaltask-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 fordemonstrating Takeda leadership behaviors 

MinimumRequirements/Qualifications: 

• BSc Degree, preferred. BA accepted. 

• 10+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience orcombination 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 andexpertise to guide team inestablished and buildingappropriate regulatory strategy. 

• Strong oral and written communications, managing and adhering to timelines, negotiation skills,integrity and adaptability. 

• Demonstrates acceptable skills with increasing independencein the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactivelyidentifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 

• Must work well with others and within global teams. 

• Acceptable and independent skillsin the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactivelyidentifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation isan important factor as you consider the next step in your career. We are committed toequitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

For information about our benefits, please clickhere.

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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Job Exempt