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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 offers hybrid working, requiring 3 days a week / 12 days a month based in office.
Job Purpose:
Responsible for managing with limited supervision all regulatory maintenance activities of an assigned portfolio with a focus on production transfer projects. The role will represent regulatory affairs and serve as the single point of contact for cross-functional project teams, providing strategic direction on production transfer projects, driving and monitoring progress and deliverables.
About the Role
Major accountabilities:
- Manage manufacturing transfer projects and represent regulatory affairs in cross-functional teams
- Ensure with limited supervision that maintenance submissions are prepared on time and in compliance with regulatory regulations, guidelines, and in line with Novartis processes and system requirements.
- Responsible for providing strategic regulatory input for the preparation of cross functional deliverables (e.g. variations/supplements, renewals, annual reports)
- Uses regulatory expertise and portfolio knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and to achieve timely submission and approval.
- Manages timely response to HA queries and contribute to preparing strong justifications to address regulatory gaps
- Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs
- Manage preparation and finalization of documents for HA interactions
- Contribute to non-project related initiatives focused on productivity, continuous improvement, and automation
- Support other associates within Regulatory Affairs by providing training on specific topics and act as a Subject Matter Expert
Your Experience:
Education:
(required and preferred)
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Languages:
(required and preferred)
Fluency in English – Additional language is an asset.
Experiences & Skills:
- 4+ years of knowledge and experience in regulations, guidelines and regulatory processes for regulatory maintenances activities
- Regulatory experience in manufacturing site transfers
- Experience with regulatory submission and approval processes
- Experience working and delivering results in a global/matrix environment and with cross- functional teams
- Planning, execution, reporting, regulatory review, compliance and submission experience
- Ability to contribute to process improvements and operational excellence initiatives
- Reliable, timely, accurate and proactive communication as appropriate.
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.
