Regulatory Affairs Manager

Position Overview At Roche Global Regulatory Affairs, we support regulatory projects for our Sequencing portfolio in the Molecular Customer Area. This role focuses on regulatory activities for systems and software, including hardware-software instrument systems. Responsibilities Oversee regulatory document and submission compilation, including the development of submission/product registration dossiers of complex products/programs. Develop and manage parts of comprehensive global regulatory submissions and registration plans, with knowledge of USFDA regulations, including Research Use Only (RUO) and IVD marketing pathways. Interface with external stakeholders, building effective relationships and communicating their needs. Support audits by preparing, executing, and following up. Adapt to evolving regulatory environments, navigate complex situations, and influence strategies without significant guidance. Partner with stakeholders to understand needs and provide best solutions, initiating actions independently. Demonstrate leadership and agility, act with integrity, and foster an inclusive environment. Qualifications Bachelor's/Master's degree in Life Science, Data Science, or related subject, or equivalent experience. Advanced degree preferred. 3–5 years of experience with a PhD, 5–7 years with a Master's, or 6–8 years with a Bachelor's in IVDs/Medical devices/Pharma/Biopharmaceutical, with significant experience in Regulatory Affairs. Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices. Knowledge of European, US, China, and other international regulations and ability to implement quality standards. Ability to manage complex work and/or parts of global projects. Preferred Qualifications Experience with complex regulatory product launch strategies, including advertisement and promotional reviews for RUO and IVD products in Sequencing technologies. Locations Open to candidates local to Indianapolis, Branchburg, Tucson, Santa Clara, Pleasanton, or Carlsbad. Relocation assistance is not available. Salary and Benefits The expected salary range for this position based on the primary location of Indianapolis is $106,000–$197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for benefits. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form. Roche strictly prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr