Associate Director / Director - GRA Devices, Digital and Combination Products

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: November 25, 2022

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 DescriptionAbout 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 worldwideJoin Takeda as a Director, GRA Devices, Digital and Combination Products where you will Utilize technical combination product and device knowledge, regulatory expertise and global regulatory lessons learned to drive internal consistency and influence effective change management.You will also Monitors global regulatory landscape to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance As part of the Global Regulatory Affairs team you will report to Executive Director, GRA CMC Devices, Digital and Combination ProductsHow you will contribute:

• Leads the development and implementation of innovative combination product and device regulatory strategies for assigned development and commercial products
• epresents Takeda on external regulatory consortia and standards committees to influence industry best practices, policy and standards
• Serves as a mentor to other GRA Devices, Digital and Combination Products staff members staff members
• Responsible for demonstrating Takeda leadership behaviors -
• Provides leadership and guidance to GRA Devices, Digital and Combination Products regulatory strategists to ensure development and implementation of innovative global regulatory strategies for all products within assigned portfolio
• Provides technical, strategic and tactical regulatory guidance to product teams by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products
• Proactively identifies, analyzes and manages complex combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management
• Defines strategy for device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
  • Acts as combination product and device regulatory expert for GRA Devices and Combination Products team
  • Builds and manages relationships through active partnering with key internal and external stakeholders
  • Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labeling, etc) to ensure effective strategies are developed and project execution is on target
  • Relationship management and constructive partnering with global Health Authorities (e.g., FDA, EMA, PMDA, NMPA, Competent Authorities, etc.)Minimum Requirements/Qualifications:
    • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
    • 10+ years of pharmaceutical Regulatory CMC and Device experience, including experience as a Device regulatory lead for drug-device combination products; international experience strongly preferred.
    • Staff management experience is a plus
    • Experience leading cross-functional submission teams
    • Proven ability to provide strategic regulatory guidance to drug-device combination product and device development, registration, and post-market support teams
    • Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (i.e., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, etc.)
    • Software as a Medical Device (SaMD) / digital devices experience is a plus
    • Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development and post-market support
    • Able to identify, prioritize and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance
    • Demonstrate leadership, problem-solving ability, flexibility and teamwork
    • Exercise good judgement in elevating and communicating actual or potential issues to line management
    • Active participation in external Agency/Industry groups/forums expected
    • Excellent written and oral communication skills requiredWhat Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursement
      • 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.Base Salary Range: $156,800 to $224,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqIn accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#RM-LEEO StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

Keywords: Takeda Pharmaceutical, Cambridge , Associate Director / Director - GRA Devices, Digital and Combination Products, Executive , Cambridge, Massachusetts