Regulatory Affairs Manager

Roche

Regulatory Affairs Manager managing regulatory document compilation and global submissions for diagnostics at Roche. Utilizing knowledge of USFDA regulations to support innovative healthcare solutions.

Posted 5/28/2026full-timeIndianapolis • California, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $106,000 - $197,000 per yearWebsite

About the role

Key responsibilities & impact

Oversee regulatory document and submission compilation, including the development of complex submission/product registration dossiers.
Develop and manage comprehensive global regulatory submissions and registration plans.
Interface with external management and understand the structure, key roles, and responsibilities of external customers/stakeholders.
Build effective and enduring external relationships and apply effective stakeholder management practices.
Contribute to audits by supporting preparation, execution, and follow-up.
Lead the organization to adapt to evolving regulatory environment and requirements.
Interpret and apply understanding of regulators' thinking to projects and apply strategies to different regions without significant guidance.
Proactively create unique/innovative regulatory strategies and approaches to avoid regulatory obstacles and accelerate approvals.
Partner with stakeholders to understand and provide best solutions.
Initiate activities independently and make decisions outside of scope/comfort zone.

Requirements

What you’ll need

Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
3-5 years experience with a PhD degree.
5-7 years with Masters degree.
6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
Demonstrated the ability to manage more complex work and/or at parts of global projects.

Benefits

Comp & perks

A discretionary annual bonus may be available based on individual and Company performance.
Benefits detailed at the link provided.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsproduct registrationaudits preparationregulatory strategiesquality standardsDaily ManagementContinuous ImprovementIVDsMedical devicesPharma

Soft Skills

stakeholder managementrelationship buildingindependent decision makingadaptabilityinnovative thinkingcommunicationcollaborationproblem solvingleadershipproject management