Director Global Regulatory Affairs - Precision Medicine and Digital Health

Initial Therapeutics, Inc.; United States; Remote; USD 169,000 - 267,000; Full time

Job summary

An established industry player is seeking a seasoned professional to lead global regulatory strategies in precision medicine and digital health. This role involves collaborating with various stakeholders to enhance product value through effective regulatory oversight. You will be responsible for ensuring compliance with global regulations, influencing cross-functional initiatives, and providing strategic guidance to development teams. If you have a strong scientific background and a passion for driving innovation in healthcare, this opportunity will allow you to make a significant impact in a dynamic environment.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Vacation

Sick Leave

Paid Volunteer Time Off

Qualifications

• 8+ years in pharma with 6 years in regulatory roles required.
• Expert in device development and regulatory submissions.

Responsibilities

• Provide strategic oversight for global regulatory strategies.
• Lead precision medicine and digital health efforts for programs.

Skills

Regulatory Strategy

Communication Skills

Collaboration

Problem Solving

Negotiation

Education

PhD

MD

PharmD

MS

Tools

Regulatory Submission Software

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 establishing and building appropriate global regulatory strategy.
• Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions.
• 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.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

169,400.00 - 266,200.00

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

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.

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