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, you9ll 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

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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 Solutions9 priorities

• Define your Network's key objectives and ensure alignment thereof with the organization9s 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 LCTs9 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 1integrator 2 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 organization9s 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 organization9s transformation to new, more Agile Ways of Working 6 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 Network9s 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 cGMP9s and QSR9s, 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 Company9s 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.

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.