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Job Description

R0128042 Regulatory Protocol Framework Lead

Takeda Pharmaceutical

USA - MA - Cambridge

About the role:

The Regulatory Protocol Framework Lead is essential for guiding Takeda’s digital health initiatives through the complex regulatory landscape. This role is responsible for developing and managing regulatory protocols, understanding reimbursement pathways, and ensuring compliance with all relevant regulations. Join Takeda as a Regulatory Protocol Framework Lead where you will develop and implement comprehensive regulatory strategies to support the approval and commercialization of digital health products globally. You will also ensure compliance with local and global regulations and standards, staying informed about regulatory changes and updating protocols accordingly.. As part of the Patient Digital Solutions team , you will report to Head of Patient Digital Solutions & SaMD Service Line-Data, Digital & Technology and work with key stakeholders.

How you will contribute:

• Develop and implement comprehensive regulatory strategies to support the approval and commercialization of digital health products.

• Engage with regulatory bodies to understand requirements and obtain necessary approvals.

• Monitor regulatory changes and adapt strategies to maintain compliance.

• Provide strategic regulatory guidance to product development and commercialization teams to ensure compliance throughout the product lifecycle.

• Develop and implement strategies to secure reimbursement for digital health products.

• Engage with payers and healthcare providers to understand reimbursement requirements and pathways.

• Prepare and submit documentation to support reimbursement applications, ensuring compliance with regulatory guidelines.

• Collaborate with market access teams to align reimbursement strategies with business objectives.

• Develop and manage regulatory protocols to ensure compliance with regulations for digital health products.

• Conduct regulatory assessments and audits to identify and address compliance issues.

• Collaborate with product development, marketing, and commercial teams to ensure regulatory requirements are integrated into all stages of product development and commercialization.

• Ensure all regulatory documentation is accurate, complete, and submitted in a timely manner.

• Work closely with the Head of Digital Health and other stakeholders to ensure regulatory strategies align with business objectives.

• Partner with internal and external stakeholders, including regulatory bodies and healthcare providers, to support regulatory and reimbursement efforts.

• Act as a key point of contact for regulatory matters within the digital health team, fostering alignment and collaboration across teams.

• Provide regulatory expertise and training to cross-functional teams to enhance their understanding of regulatory requirements and processes.

• Lead the communication strategy for regulatory updates and changes, ensuring clear and effective dissemination of information.

• Prepare and present regulatory findings and recommendations to internal and external stakeholders.

• Ensure that regulatory documentation is well-documented and aligns with Takeda’s standards and requirements.

• Maintain open and transparent communication channels with regulatory authorities, internal teams, and external partners.

• Continuously seek opportunities to improve regulatory protocols and processes.

• Stay informed on industry trends and best practices, applying them to drive innovation within the regulatory function.

• Foster a culture of continuous improvement, encouraging team members to identify and implement enhancements.

• Lead initiatives to streamline regulatory processes, reduce timelines, and improve efficiency without compromising compliance.

• Identify potential regulatory risks and develop mitigation strategies to address them.

• Ensure proactive risk management by staying ahead of regulatory changes and anticipating their impact on the business.

• Collaborate with legal and compliance teams to ensure all regulatory risks are adequately managed and mitigated.

Minimum Requirements/Qualifications:

• Essential

• Degree in in a technically relevant field (e.g., Regulatory Affairs, Engineering, Information Technology, Computer Science, Health Economics, Public Health) required;

• Minimum of 3-5 years of experience in regulatory affairs, compliance, or a related field within the healthcare industry and experience in SaMD( Software as a Medical Device).

• Proven track record in developing and managing regulatory strategies for digital health products.

• Experience with regulatory requirements and standards is essential.

• Experience in navigating reimbursement pathways and securing coverage for digital health products.

• Deep understanding of regulatory requirements, guidelines, and standards.

• Expertise in developing and managing regulatory protocols, ensuring compliance with local and international standards.

• Strong analytical skills with the ability to interpret and present complex regulatory information clearly.

• Familiarity with software development processes and methodologies, particularly Agile, to integrate regulatory requirements into product development.

• Familiarity with software development processes and methodologies, particularly Agile.

• Strong communication skills with ability to articulate and optimize design based on the value to the user and the business, lead ideation sessions and workshops;

• Experience working in a life sciences environment and/or familiarity with Takeda strongly preferred.

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" in accordance with Takeda's Hybrid and Remote Work policy.

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.

For Location:

Cambridge, MA

U.S. Base Salary Range:

$149,100.00 - $234,300.00

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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time