摘要
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:
This role can be based in either our White City, London office (hybrid working, requiring 3 days per week) or Novartis site in Schaftenau, 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.
About the Role
Major accountabilities:
- 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.
Your Experience:
- 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.