Job Details

ID #44383012
State Iowa
City Des moines
Full-time
Salary USD TBD TBD
Source Takeda Pharmaceuticals
Showed 2022-07-26
Date 2022-07-26
Deadline 2022-09-24
Category Et cetera
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Director, Global Regulatory Affairs Devices and Combination Products - Remote

Iowa, Des moines, 50301 Des moines USA

Vacancy expired!

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 worldwide.Join Takeda as a Director, Global Regulatory Affairs (GRA) Devices and Combination Products where you will lead the development and implementation of innovative combination product and device regulatory strategies for assigned development and commercial products. You will also use technical combination product and device knowledge, regulatory expertise and global regulatory lessons learned to lead internal consistency and influence change management. As part of the Global Regulatory Affairs CMC team, you will report to the Executive Director, GRA CMC Devices, Digital and Combination Products and work 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).How you will contribute:Demonstrate Takeda leadership behaviors

Provide guidance to GRA Devices and Combination Products regulatory strategists to ensure development and implementation of innovative global regulatory strategies for all products within assigned portfolio

Provide technical and strategic regulatory guidance to product teams by defining and optimizing global regulatory strategies on the development, registration, commercialization and life cycle management of assigned products

Analyze and manage complex combination product and device-related regulatory risks, ensuring timely communication with relevant team members and management

Develop / lead development of device-related dossier content for global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)

Be a combination product and device regulatory expert for GRA Devices and Combination Products team

Build and manage relationships through active partnering with with important stakeholders

Work 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 required

Experience leading cross-functional submission teams

Experience providing strategic regulatory guidance to drug-device combination product and device development, registration, and post-market support teams

Experience with 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 and their amendments/supplements)

Understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development and post-market support;

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 required

Active participation in external Agency/Industry groups/forums expected

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: $160,300 to $229,000, 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 seq#LI-LC1EEO 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

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