Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors

3316 Takeda Development Center Americas•Boston, MA

5d•Hybrid

About The Position

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. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors, you will provide leadership for the development and implementation of innovative pure device and combination product regulatory strategies particularly pertaining to the development, registration, commercialization and life cycle management with a focus on Human Factors, ensuring that regulatory filings are of high quality and right first time.

Requirements

BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline, Advanced Degree Preferred.
10+ years of experience in a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience is a plus.
A minimum of 10 years of relevant industry experience (e.g., combination of pharmaceutical and medical devices).
2 years management of direct reports desired.
Experience working on cross-functional teams including technical quality and commercial manufacturing and supply stakeholders, leading and influencing on regulatory positions, to set programs on course for regulatory success
Proven expertise and experience in the area of Human Factors and allied fields for drug-device combinations
Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.) is strongly preferred, including expertise with proposing science-based, data-driven regulatory positions and conducting negotiations with regulators
Demonstrates emerging 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 are required, with cross-organization stakeholder engagement
Ability to self-direct within a project team and properly manage tasks and work expectations, lead, be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy
Active participation in industry forums is expected
Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance, with an emphasis on Design Control issues.

Nice To Haves

Advanced Degree Preferred.
international experience is a plus.
2 years management of direct reports desired.

Responsibilities

Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Human Factors, and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
Globally influences and serves as a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry on Human Factors
Influences changing regulations and guidance documents; and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy of Human Factors
Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives on drug-device combination and allied filings.
Responsible for demonstrating Takeda leadership behaviors
Acts as Foundational Subject Matter Expert/Platform Lead within Takeda on the topic of global regulation pertaining to Human Factors for devices and combination products
Provides tactical regulatory guidance on Human Factors to product teams in line with global regulatory strategies
Develops strategies, tools and trainings to develop the combination product regulatory team on Human Factors
Authors, reviews, provides critical assessments and gives input on drug-device combination regulatory strategies in regulatory filings through clinical development and commercial product lifecycle
Lead regulatory strategy, briefing book authoring and meetings with global health authorities
Reviews and approves medical device development design control documentation, including technology transfer protocols, design verification and validation protocols and reports, technical reports, human factors protocols and reports, etc., to assure alignment with regulatory requirements and standards
Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
Supports and/ or leads assigned 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 support 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 implemented and project execution is on target
Evaluate new business development opportunities or participate on due diligence teams.
Develops and maintains constructive relations with key internal and external stakeholders.
Develops CMC Device & Combination product staff on the subject of Human Factors