Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients
even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and welcome to where we thrive together!

The Role:

Ths role will be based at the Novartis Schaftenau site in the Tyrol, Austria.

As Global Program Regulatory Manager Medical Devices & Drug/Device Combination Products you will independently provide strategic and operational global medical device regulatory direction and documentation for projects/products. This includes those projects/ products in development, registration and approval/post approval. You will make informed regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals.

• You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance.

• Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying the required documentation for timely global submissions to deadline.

• Author and/or review high-quality RA MD documentation for HA submission, applying agreed RA MD Global regulatory strategies, current regulatory trends and guidelines.

• Proactively communicate RA MD regulatory strategies, risks and key issues throughout the life cycle, to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.

• Lead, prepare and communicate RA MD Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.

• Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.

• Establish and maintain a single point of contact with global HAs.

• Represent department on due diligence teams for in-licensing and divestment opportunities.

• Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology,Biology) or equivalent

• Medical device & Drug/Device Combination Products regulatory affairs experience, in the pharmaceutical and/or medical device industry.

• Good knowledge and experience in medical device & Drug/Device Combination Products regulatory submissions and approval processes, with understanding of product development life cycle.

• Ability to critically evaluate data from a variety of sources, work in interdisciplinary teams and prioritise activities, timelines and workload.

• Strong interpersonal skills and experience working in a complex, cross functional organization.

• Fluency in English.