Regulatory Affairs Coordinator
vor 3 Wochen
70 This is the number of countries that rely on our Swiss regulatory approvals for innovative products.
Provides effective operational and regulatory support to Novartis as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
Major Accountabilities:
- Coordinates and prepares high quality submissions of regulatory dossiers for assigned products to Swissmedic in time.
- Responsible for regulatory maintenance activities: CMC variation, renewals and additionally assigned tasks (e.g. variations, safety updates, annual reports, risk minimization documents).
- Manages printed text material according to the quality standards and timelines set by Swissmedic, internal SOPs and KPIs, and other stakeholders. Involves the relevant local and global line functions as appropriate
- Coordinates the process of artwork creation and approval and performs text comparisons of artwork components, including final release of Ready for Print (RfP) and approval of
printed packaging material sheet (PPMS).
- Ensures optimal launch preparations for new products in close collaboration with the regulatory affairs manager (RAM), product management, local and global supply chain management (SCM) and quality assurance (QA).
- Tracks and communicates regulatory relevant activities and commitments, approvals, deadlines, events and KPIs for assigned products. Maintains country specific information in DRA-relevant databases and archives.
- Contribute to process improvements and participate in the creation of process descriptions, performs assessments on guidance’s
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
What you'll bring to the role:
- Bachelor in life sciences / Commercial Qualification with experience in Pharma Industry
- German: Fluent; English: Fluent; French: basic knowledge
- 2-3 years of experience in Regulatory Affairs
- Cross Cultural Experience
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**
Global Drug Development
**Business Unit**
REG AFFAIRS GDD
**Country**
Switzerland
**Work Location**
Rotkreuz
**Company/Legal Entity**
Novartis Pharma Schweiz AG
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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