Director Global Regulatory Affairs - Precision Medicine and Digital Health

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Job Description

POSITION OBJECTIVES:

• Responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas
• Establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests and digital tools to ensure goals/objectives are met.

ACCOUNTABILITIES:

• Responsible for overseeing the precision medicine and digital health efforts for assigned programs..
• Ensures global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
• Ensures 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. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.
• Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.  Influence non-direct reports within the therapeutic area, across GRA and across the enterprise.
• Provide regulatory strategy support to diligence for licensing opportunities as appropriate
• 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.
• Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Solid scientific background, PhD., M.D., PharmD, MS
• A minimum of 8 years of pharmaceutical industry experience.  This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience. 
• Expert knowledge of device development, registration and maintenance regulations with experience in championing innovation in technical areas.
• Comprehensive understanding of biomarker strategies and implications for drug development.
• Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
• Understanding of scientific principles and regulatory Device requirements relevant to global drug development and post-market support, including recent EU MDR and IVDR. 
• 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 global regulatory strategy.
• Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions.
• 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 global regulatory strategy.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills.  Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.

Takeda Compensation and Benefits Summary

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

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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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