Senior Regulatory Affairs Manager, Near Patient Care

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At Roche, we celebrate individuality and foster an inclusive culture that encourages personal expression, open dialogue, and genuine connections. We value and respect each individual, supporting your growth both personally and professionally. Our mission is to prevent, stop, and cure diseases, ensuring access to healthcare for all, now and in the future. Join Roche, where every voice matters.

The Position

At Roche, our passion lies in transforming patients' lives with fearless decision-making and action. We are committed to scientific rigor, ethics, and broad access to medical innovations—today and tomorrow.

Our Global Regulatory Affairs team aims to be the world's leading regulatory organization, championing patient access to diagnostics. We work on regulatory projects and overarching topics, fostering an open-minded environment with collaboration across departments and countries.

The main responsibilities in this role include:

• Securing regulatory approvals for products in designated markets through collaboration with other functions.
• Coordinating and compiling documentation for submissions to meet product registration timelines.
• Maintaining regulatory approvals, permits, and licenses throughout the product lifecycle via effective change controls.
• Ensuring regulatory activities and strategies are efficient and successful through clear agreements with stakeholders and external partners.
• Understanding, communicating, and implementing regulatory requirements and strategic considerations transparently within the organization.
• Driving activities with innovation, agility, and VAAC leadership principles.

The Opportunity

• Overseeing development of complex regulatory submission dossiers and managing global registration plans, potentially mentoring junior team members.
• Managing external relationships with stakeholders, supporting audits, and ensuring effective communication of needs and requirements.
• Leading adaptation to evolving regulatory environments, solving complex health authority issues, and influencing strategies to accelerate approvals worldwide.
• Partnering effectively with stakeholders, managing relationships, and influencing decision-making to shape product development and regulatory strategies.
• Making independent decisions, initiating activities, and demonstrating good judgment and proactive problem-solving.
• Driving innovation, troubleshooting issues, and leading problem-solving activities to ensure compliance and efficiency.
• Building a collaborative environment, resolving conflicts, and communicating complex ideas clearly and effectively.

Who You Are

• Bachelor's or Master's in Life Science, Data Science, or related fields; advanced degrees are a plus.
• Experience in Daily Management and Continuous Improvement practices.
• 5-10 years (PhD), 7-10 years (Master's), or 8-10 years (Bachelor's) in Regulatory Affairs within IVDs/Medical Devices/Pharma/Biopharma, with significant experience.
• Technical knowledge of medical devices or IVDs.
• Understanding of international regulations, especially European, US, China, and ability to interpret quality standards.
• Proven ability to manage complex projects and global initiatives, with expertise in Near Patient Care devices and strategic FDA partnerships preferred.
• Experience with Continuous Glucose Monitoring (CGM) is advantageous.

Locations

Preferred locations include Indianapolis, Tucson, Pleasanton, Santa Clara, Branchburg, or Washington DC. Remote work arrangements are possible. Relocation assistance is not provided.

Compensation & Benefits

The salary range for Indianapolis is $121,000 to $226,400, with actual pay based on experience and location. A discretionary annual bonus and comprehensive benefits are included.

About Roche

We are dedicated to advancing science and healthcare access worldwide. Our 100,000+ employees are committed to delivering innovative healthcare solutions that impact millions of lives globally.

Equal Opportunity Employment

Roche is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination based on race, gender, age, disability, veteran status, and other protected characteristics. Accommodations for applicants with disabilities are available upon request.

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