Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Takeda Pharmaceutical Co.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda seeks a seasoned Regulatory Affairs professional to guide strategic and tactical global regulatory plans for precision medicine and digital health assets. You will partner with cross-functional teams and lead submissions with FDA, EMA, and other regulators.

The role emphasizes device and diagnostic regulatory expertise, life-cycle management, and proactive risk mitigation, with remote work options within the US and a base salary range reflected in regional pay practices.

Qualifications

• Requires a scientific bachelor’s degree; advanced degree preferred.
• Minimum 5 years in regulatory affairs, with devices/diagnostics experience preferred.
• Proven track record in global regulatory strategy for digital health/diagnostics/precision medicine.

Responsibilities

• Develop and lead global regulatory strategies for precision medicine and digital health programs.
• Provide regulatory guidance to global development teams and cross-functional partners.
• Engage with FDA, EMA and other health authorities on submissions and inspections.
• Coordinate lifecycle management activities including submissions, changes, and regulatory maintenance.
• Influence cross-functional teams and drive continuous improvement in regulatory processes.

Skills

Regulatory strategy development

FDA/health authority engagement

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in scientific discipline

Advanced degree (PhD/MD/PharmD/MS) strongly preferred

Tools

Regulatory submissions (IND/IDE/MAA/510K)

Device regulatory knowledge (EU MDR/IVDR)

Job description

Job Description Objective / Purpose Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.

Accountabilities

Responsible for developing and leading the global regulatory strategies for precision medicine and digital health efforts for assigned programs. Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility. Partner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets. Ensures therapeutic asset’s 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 management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internal governance technical review committees, key global health authority meetings and with external partners. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence cross-functional colleagues within the therapeutic area, across GRA and across the enterprise. Provide training to cross-functional teams to enhance their understanding of regulatory requirements and processes. Helps implement a culture of continuous improvement to improve regulatory processes, and drive the adoption of innovation and best practices within the regulatory function. Provide regulatory strategy support to diligence for licensing opportunities as appropriate, including regulatory input on the selection, governance, and ongoing management of device/diagnostic partners. 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. Support external influencing activities by coordinating and contributing to regulatory/policy engagement efforts, including drafting and reviewing guidance comments and supporting trade association working groups.

Education & Competencies (Technical and Behavioral)

Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PhD., M.D., PharmD, MS) strongly preferred A minimum of 5 years of experience in regulatory affairs. Experience working with medical devices and/or diagnostics within the pharmaceutical industry strongly preferred. Proven track record in developing and managing regulatory strategies for digital health products, and/or diagnostics, and precision medicine. Expert knowledge of device development, registration and maintenance requirements 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 (i.e., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements). Understanding of scientific principles and device regulatory requirements relevant to global drug development and post-market support, including 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. Demonstrates strong verbal and written communication skills, with the ability to translate complex regulatory concepts into clear, stakeholder-tailored communication

Location: Remote within the US

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. For Location: Massachusetts - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00 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.

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.

Locations Massachusetts - Virtual

Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company Culture

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.