At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access – Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
Every day, we rise to the challenge to make a difference and here’s how the Director, Device Technical Regulatory role will make an impact.
Key responsibilities for this role include:
- Accountable to define device regulatory requirements and regulatory strategy to development teams to ensure readiness for medical device (MD) and combination product (CP) approvals. Critically review, approve, and lead strategy for global regulatory submissions for device component of all drug / biologic combination products.
- Responsible for company Notified Body (NB) strategy (e.g. selection of NBs for different device technology and/or therapeutic areas) that enables cross-European market launches and post-launch maintenance.
- Drive device regulatory strategies with respect to clinical development, commercial development and CTD submissions. Lead the program team in the development of strategies and plans that ensure compliance to regulations, legislations and standards whilst ensuring appropriate balancing for commercial operation and site compliance needs.
- Function responsible to create and own processes for Technical File dossiers, obtaining NB Opinions, GSPRs and MDD / MDR requirements.
- Directly responsible for liaising with NBs and Competent Authorities to secure CE approvals and NB opinions for all MD and DC for combination products.
- Responsible for the development of technical briefing documents on device development and regulatory plans.
- ccountable for leading and managing a device technical regulatory team to successfully enable development, approval. commercialisation and lifecycle management of deliver MD and DC programs aligned with Viatris business plans.
- Responsible to partner with Regulatory Affairs Science Teams to deliver the device component (inc NB Opinions) of combination products for submission.
- Partners with cross-functional teams across the organisation, and in partner organisations, to ensure delivery of regulatory component of integrated project plans.
- Ensure definition, development, maintenance and execution of regulatory plans for MD and DC/CP programs integrated with R&D, Clinical, Regulatory, Commercial and Manufacturing milestones.
- Provide regulatory leadership and planning expertise across the relevant device portfolios, and share such knowledge with peers as appropriate for the advancement of the organisation.
- Ensure the regulatory strategies and content are appropriate to the business need, and actively participate in business go/no go decisions on diligence / BD contracts/acquisitions.
- Identify opportunities for participation in external industry and regulatory consortia to represent Viatris and provide positive contribution to current and future challenges within the MD / CP space.
- Maintain a real time view of medical device and combination product submissions, approvals, recalls, 483s etc and use this information to contribute to portfolio level discussion.
The minimum qualifications for this role are:
- Degree in a pharmaceutical development (science/engineering) discipline, or equivalent
- Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
- Experience in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content, OR experience in drug product development, specifically with a focus on clinical interface, regulatory plans and high-level strategy planning.
- Demonstrable track record of competence in leading program teams in problem solving approaches to technical regulatory issues.
- Knowledge of device design controls, ISO, FDA and EU/MDR requirements as applicable to device design, development and regulatory approval.
- Experience of working at a team level where leadership and influencing skills have been applied.
- Well-developed communication skills to lead or facilitate effective technical and project discussions.
- Is able to communicate regulatory information to key stakeholders.
- Willingness to travel on an as-needs basis. averaging 10% of working year.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.