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Job description
Overview
Introduction:
Join a global leader driving breakthroughs in neuroscience and rare disease treatment by leading regulatory strategies that enable life-changing therapies to reach patients worldwide. As the Director of Global Regulatory Chemistry, Manufacturing, and Controls (CMC) for Medical Devices and Combination Products, you will combine deep scientific expertise with practical regulatory leadership to advance an innovative device portfolio. Your role will have a direct impact on patients' lives while supporting a culture that values integrity, collaboration, and a relentless focus on scientific excellence.
You’ll partner across functions, including technical development, quality, device engineering, and clinical teams, to set and execute the global Regulatory CMC strategy. Responsible for a diverse portfolio of intrathecal delivery systems, connected drug-device technologies, and combination products, you will balance visionary strategy with detailed execution. Your leadership will help shape regulatory guidance, author key submissions, and foster cross-disciplinary collaboration within an inclusive and mission-driven environment.
Role Overview:
As a vital member of the Product Delivery Solutions team, you will lead comprehensive end-to-end CMC regulatory strategies and operations for a diverse medical device portfolio. Your leadership ensures regulatory compliance, product quality, and continuous supply, while mentoring your team and championing cross-functional and regional collaboration. Reporting directly to the VP, Head of Product Delivery Solutions, you will contribute meaningfully to strategic business objectives and improve patient outcomes. This hybrid role is based in Cambridge, MA, with relocation support available.
Key Responsibilities
Strategic Leadership
Develop and implement innovative regulatory CMC strategies aligned with business goals and patient needs.
Lead global regulatory strategy formation and ensure compliance with international standards.
Drive adoption of new regulatory approaches to enhance patient value and product differentiation.
Contribute to strategic planning and roadmap development as a key member of the Global Regulatory CMC Leadership Team.
Operational Execution
Oversee the quality, content, and timely submission of regulatory CMC applications worldwide.
Manage regulatory submissions, dossier compliance, and variations for drug-device combination products.
Provide regulatory support for Quality systems, including change control, deviation, and inspection management.
Establish robust partnerships with health authorities, trade associations, and internal teams to inform policy and ensure regulatory compliance.
Lead and mentor global and regional regulatory teams, managing critical health authority interactions and regulatory issues.
Standardize processes, generate metrics, and leverage outsourcing to drive operational efficiency.
Foster a culture of discipline, precision, and continuous improvement aligned with organizational values.
Cross-Functional Collaboration
Work closely with technical development, quality, device engineering, and clinical teams to ensure alignment and integration of regulatory strategies.
Promote cross-functional collaboration to achieve seamless regulatory execution and supply continuity.
Maintain ethical, customer-focused interactions with a broad range of stakeholders and industry peers.
Leadership Profile
Visionary and collaborative leader with a global mindset and proven regulatory CMC expertise.
Exceptional communicator skilled in negotiation and stakeholder engagement at all levels.
Passionate mentor who inspires, develops, and empowers high-performing teams.
Strategic thinker committed to making a meaningful impact on patient care.
Resilient and adaptable, thriving in dynamic, fast-paced, and inclusive environments.
Embodies values of integrity, collaboration, and scientific excellence.
Qualifications & Experience
Education: Bachelor’s degree required; graduate degree preferred in life sciences, engineering, biotechnology, law, or related pharmaceutical science.
Experience: Minimum 12 years in medical device and combination product regulatory affairs, manufacturing, quality, or technical development, including at least 8 years of international CMC regulatory experience.
Proven expertise in preparing regulatory submissions and engaging with global health authorities.
Advanced knowledge of global regulations, guidelines, and product licensure requirements.
Demonstrated strategic leadership with the ability to influence industry standards.
Strong talent development and team leadership skills.
Experience with combination product regulatory affairs in mid to large pharmaceutical organizations.
Experience with Class III implantable devices and diagnostic regulatory frameworks such as IVDR.
Retained Executive Search
This confidential search is conducted solely by Talencio in collaboration with the hiring organization. All outreach and communication will be managed directly by our retained search team.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Other
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Note: This description reflects the responsibilities and requirements of the role as provided. Rumors of role status or application status (e.g., smart prompts) should not be assumed as current fact.
Retained Executive Search: This confidential search is conducted solely by Talencio in collaboration with the hiring organization. All outreach and communication will be managed directly by our retained search team.
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Worksite address
bridgeport, CT, 06610, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.