Senior Regulatory Expert for Device and Combination Product Development

7 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Join Takeda Pharmaceutical as a Senior Regulatory Expert for Device and Combination Product Development. We are seeking an experienced professional to lead the development and implementation of innovative device and integral/co-packaged combination product regulatory strategies in the US.

About the Role:
Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. As a Senior Regulatory Expert, you will be responsible for shaping global regulatory best practices, driving internal consistency, and influencing effective change management. You will work closely with cross-functional teams to develop and implement regulatory strategies for assigned asset programs in the US.

Responsibilities:
* Develop and implement innovative device and integral/co-packaged combination product regulatory strategies for development, registration, commercialization, and life cycle management of assigned asset programs in the US
* Utilize technical combination product knowledge, regulatory expertise, and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency, and influence effective change management
* Monitor the regulatory landscape in the US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance
* Influence and be generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in industry for US regulatory activities for devices and combination products
* Build and manage strong working relationships through active partnering with key internal and external stakeholders
* Combine knowledge of scientific, regulatory, and business issues to ensure regulatory filings are of high quality and right first time

Requirements:
* BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline, higher degree preferred
* 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for device and drug-device combination products in the US
* Experience working on cross-functional submission teams
* Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration, and post-market support
* Experience leading/supporting interactions with health authorities is strongly preferred
* Emerging leadership, problem-solving ability, flexibility, and teamwork skills

Benefits:
Takeda offers a competitive salary range of $205,100.00 - $322,300.00 and a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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