Network Lead Core Lab (RA)

F. Hoffmann-La Roche AG; Indianapolis (IN); On-site; USD 200,000 - 371,000; Full time

Job summary

Roche, a global leader in diagnostics, seeks a Core Lab Network Lead to drive regulatory strategies and submissions across the Core Lab portfolio. You will translate customer needs into priorities and work with Functional Partners and Squads to deliver high-quality dossiers and registrations.

Based in a global role, you will foster agile ways of working and ensure regulatory readiness across regions, enabling rapid patient access to diagnostics solutions.

Qualifications

• 10+ years in Regulatory Affairs within diagnostics industry or related field.
• Knowledge of IVD, Pharmaceutical, or Medical Device regulatory requirements.
• Experience with global submissions for US FDA, EU Notified Bodies, and international regions.

Responsibilities

• Lead and translate customer and business needs into regulatory priorities.
• Drive development of global regulatory strategies and dossiers.
• Collaborate across networks to deliver regulatory plans and ensure timely submissions.
• Balance compliance with innovative approaches to meet customer needs.

Skills

Regulatory affairs experience

Strategic thinking

Education

Science degree (Bachelor or Advanced)

Job description

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.

The Position

As the Core Lab Network Lead, you will be a member of the Regulatory Affairs Leadership Team (RLT). You will be a key interface in translating customer and business needs, as well as strategy on several levels into clear priorities for Regulatory Affairs, so as to guide the focus of Regulatory Affairs Functional Partners and Squads. As such, you will closely work with the Core Lab Customer Area, the corresponding Functional Partners who link to Lifecycle Teams (LCTs), as well as collaborate across Networks to deliver comprehensive and successful Customer Solutions. In your work with Functional Partners and Squads, you’ll apply Vision, Architecture, Coach and Catalyst (VACC) principles to encourage: smart risk taking development of global regulatory strategies that weigh the requirements of all regions early in development, creative solutions that maintain compliance while helping to advance the customer needs creation of global dossiers that allow for parallel submissions globally, and inclusion of innovative approaches within projects that help advance our policy objectives. Furthermore, you will interact closely with the Chapters within Regulatory Affairs to determine how to best allocate their members to Squads and teams. The Opportunity Drive regulatory strategies and deliverables to have the greatest impact for our customers: Drive the development of best in class development and submissions strategies leading to successful diagnostic solutions global registrations. Foster an agile mindset and ways of working with a focus on delivering high quality submissions Work closely with all Roche Diagnostics affiliates to ensure timely availability of registration data and dossiers to enable rapid global patient access to our product portfolio. Monitor the global regulatory environments, and provide assessments of the impact of new and changing regulations within the Core Lab Customer Area. Seek to inspire and lead the team to deliver ground-breaking solutions that will ensure that Diagnostics Solutions products are recognized as being the best in the Diagnostics industry and maintains our #1 position in the future. Drive business results and customer value: Take an enterprise wide view to provide insights that help advance the regulatory strategies and deliveries across the Core Lab portfolio. Be accountable for the delivery of projects and Squads within your Network towards the Diagnostics Solutions’ priorities. Define your Network's key objectives and ensure alignment thereof with the organization’s business strategy. Building on priorities from the Core Lab Customer Area, define common objectives for the Network. Develop a long term vision and backlog for the Network and its Squads and derive resource planning and budget cycles therefrom. Advance the work of the Network, making tradeoffs and breaking silos: Coordinate with Functional Partners to aggregate upcoming LCTs’ needs and upcoming priorities, to better understand upcoming resource demands on the Network. Build and share this foresight on resource demands to the Chapter Leaders, to best enable Network alignment and resource allocations. Own decisions regarding prioritization of work and resource allocation across Squads within the Network. Break down silos and improve working effectiveness as an 'integrator' across the organization as needed; in particular through collaboration with other Networks Leaders and stakeholders to resolve escalated bottlenecks and dependencies, as well as rebalance work & help in line with greater strategic priorities. Empower and enable Squads within the Network: Provide guidance and mentorship for Squads in accordance to Servant-Leadership and VACC principles. Encourage Squad Leaders to seek creative and innovative approaches to the development and execution of regulatory plans and deliverables. Provide feedback on work-in-progress while ensuring autonomy of decision making by the Squad Leader. Ensure Squads proactively seek out and consider the voice of the customer in defining their priorities and outputs. Enable the organization’s New Ways of Working Act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors. Model behaviors to support the organization’s transformation to new, more Agile Ways of Working – e.g. new decision making/governance practices, collaboration, etc. As a Network Lead you: Will be the key translator of customer & business strategy and priorities to Regulatory Affairs, the Core Lab Network’s focus and squads progression. Bring a mix of passion, functional knowledge and customer-obsession to your work to inspire, motivate and guide Squads within the network. Are committed to cross-functional collaboration and breaking down silos to achieve the best results for the organization. Have the ability to navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skill. As per delegation by the person responsible for regulatory compliance (PRRC), incumbent is responsible to ensure that the technical documentation (as defined in IVDR Annex II) and the EU declaration of conformity (as defined in IVDR Annex IV) are drawn up and kept up-to-date [acc. to Article 15 (3) (b) IVDR/MDR].

Who you are

Bachelor or Advanced degree in science or a related field with 10+ years of experience in Regulatory Affairs within diagnostics industry or a related field. General understanding of the Diagnostics industry, lifecycle & development process and global trends. History of successful interactions with regulatory bodies. Knowledge in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP’s and QSR’s, ISO13485 and 27001. Experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China). Past experience of working as/with cross functional expert(s) on projects. Demonstrates courage, vision and drive to be at the forefront of innovative change. Strong business and financial acumen with an enterprise mindset. Leadership skills: Consistent record of building collaborative relationships with peers and teams, helping cross-functional teams address strategic opportunities and solve problems across the organization. Demonstrated experience of working in a matrixed organization, ability to build strong relationships and effective stakeholder management. A desire and openness to learning and continuous improvement. Senior management skills. Senior-level experience leading, motivating, coaching, and developing teams to drive customer focus in our mindset, work priorities and collaborative behaviors. Evidence of strong strategic thinking, communication, planning and organizational skills required, e.g., through experience successfully leading strategic initiatives. Able to foster positive partnerships through effective influencing, negotiation and conflict management skills to achieve alignment up and down the organization. Commitment through collaboration and breaking down of siloes. Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster and build important relationships with customers and key stakeholders.

Locations

This position is based in Indianapolis, Branchburg, Penzberg, Mannheim or Rotkreuz. At the Company's discretion, an exception to the location requirement could be made under extraordinary circumstances. As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Salary

The expected salary range for this position based on the primary location of Indiana is $199,600-$370,600. 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

This position also qualifies for the benefits detailed at the link provided below.

Who we are

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.

If you have a disability and need an accommodation in relation to the online application process.

Equal Opportunity

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And 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. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.