Senior Regulatory Affairs Manager, Near Patient Care

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

At Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.

In this role, your main purpose and tasks will cover the following:

• Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.

• The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.

• The obtained Regulatory approvals/ permits/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls.

• The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc).

• The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.

• The activities are driven by a mindset of innovation, agility and the principles of VAAC leadership.

The Opportunity

• Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of more complex products/programs. Develops and manages at least parts of comprehensive global regulatory submissions and registration plans. May act as mentor for more junior team members in this area.

• External interface management: Understands the structure, key roles and responsibilities of external customers/stakeholders. Understands and communicates timely and effectively the needs of external customers/stakeholders. Builds effective and enduring external relationships and applies effective stakeholder management practices. Actively contributes to audits by supporting preparation, execution and follow up.

• Regulatory knowledge and strategy: Leads the organization to adapt to evolving regulatory environments and requirements. Experience in solving complex, critical health authority issues or equivalent. Understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. Ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.

• Stakeholder management and influencing: Effectively partners with stakeholders to understand and provide best solutions. Takes initiative to address problems or opportunities and involves stakeholders for best solutions. Develops relationships that significantly influence the current and future direction for Roche and our products. Is skilled at managing and influencing peers. Fosters an exchange of ideas amongst key stakeholders to be able to shift perspectives to reach a common agreeable outcome. Negotiates with stakeholders and creates win-win compromises.

• Decision making: Has courage to make decisions even outside of scope/comfort zone. Proactively Initiates activities independently and initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner.

• Innovation and problem solving: Drives innovation across the organization/sites. Advocates for and helps progress new ideas that add business value. Sees the value in others' unique differences. Is entrepreneurial; seizes new opportunities. Works to drive new ideas into the business. Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur and actively drives mitigation strategies to avoid them. Leads others in problem-solving activities.

• Teamwork and communication: Is able to pull people together around a common goal. Seeks to understand and build on different perspectives to enhance outcomes. Addresses and resolves conflict by creating an atmosphere of openness and trust. Brings out the best in people and teams. Makes people feel that they are truly heard. Expresses complex ideas fluently and clearly. Encourages direct and open discussions about important issues. Can be depended on to tell the truth regardless of the circumstances. Recognizes and reflects/articulates multiple points of view on an issue. Provides honest input even in difficult situations. Speaks up and actively participate. Creates an environment of recognition and appreciation.

Who You Are

• Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks. Advanced degree is considered an advantage.

• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

• 5-10 years experience with PhD degree, 7-10 with Masters degree and 8-10 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.

• Technical understanding of medical devices or IVDs

• Knowledge of European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.

• Has demonstrated the ability to manage even the highest complexity of work and/or global projects.

• We are seeking expertise with Near Patient Care devices particularly with experience in strategic partnering with the FDA (preferred).

• Experience with Continuous Glucose Monitoring (CGM) is preferred.

Locations:

You are local to Indianapolis, Tucson, Pleasanton, Santa Clara, Branchburg, or Washington DC. We will consider remote work arrangements for this position.

Relocation assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Indianapolis is between $121,000 and $226,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

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, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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