Associate Director, GRA Devices, Digital and Combination Products

Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 26, 2023

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 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 worldwide. Join Takeda as a Associate Director, GRA Devices, Digital and Combination Products where you will be r esponsible for the development and implementation of innovative combination product and device regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products You will also m onitors global regulatory landscape to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance How you will contribute:

• Responsible for demonstrating Takeda leadership behaviors
• Reviews and approves technical documentation, including technology transfer protocols, design verification and validation, technical reports, human factors protocols and reports, etc., to assure alignment with regulatory requirements and standards
• 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 combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management
• Informs strategy for device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
• Provides global regulatory input and guidance on product-compliance related activities including, change controls, deviations, and investigations
• 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 Minimum Requirements/Qualifications:
  • BS/BA Degree in a Scientific Discipline
  • 8+ years of Regulatory CMC and Medical Device experience, including experience as a Device regulatory lead for drug-device combination products; international experience strongly preferred.
  • Experience working on cross-functional submission teams
  • Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development, registration and post-market support
  • 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.) is strongly preferred
  • 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
  • Excellent written and oral communication skills requiredTRAVEL REQUIREMENTS:
    • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
    • Requires approximately 10-30% travel What 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 "remote" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $137,200 to $196,000 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.The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, New Rochelle , Associate Director, GRA Devices, Digital and Combination Products, Executive , Bronx, New York