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Director - Gra Devices and Combination Products
vor 5 Monaten
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and has a team of engaged employees who strive for excellence in everything they do.
**OBJECTIVES**:
- Responsible 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
- Utilizes technical combination product and device knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management
- Monitors global regulatory landscape to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance
- Builds and manages strong working relationships through active partnering with key internal and external stakeholders
- May serve as mentor to other GRA Devices, Digital and Combination Products staff members
**ACCOUNTABILITIES**:
- 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, analyses 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, Labelling, etc) to ensure effective strategies are developed and project execution is on target
**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:(**_List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. _Any minimum requirements should be noted.)_
- BS/BA Degree in a Scientific Discipline
- 10+ 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 required
**Locations**:
CHE - Switzerland Remote
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
LI-Remote
