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Apply to JobJob ID251311BRPosition TitleRegulatory Affairs Coordinator (80%)Job DescriptionProvides effective operational and regulatory support to the Novartis Pharma Switzerland Country Pharma Organization 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 Activities:

1. Coordinates and prepares high quality submissions of regulatory dossiers for assigned products to Swissmedic in time.

2. Responsible for regulatory maintenance activities: CMC variation, renewals and additionally assigned tasks (e.g. variations, safety updates, annual reports, risk minimization documents).

3. 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.

4. 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).

5. 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).

6. 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 (AIPS, DRAGON, REDI-GO, local server etc). Ensures traceability and integrity of current and past DRA records for Switzerland by accurate and timely data management in regulatory compliance databases for assigned products in close collaboration with RAMs.

7. Manages translations for regulatory documents together with the assigned RAM.

8.Ensures appropriate archiving of regulatory relevant Swissmedic documents, including correspondence.

9. Establishes and maintains close professional relationship to Swissmedic (e.g. related to operational regulatory tasks) and other internal/external stakeholders and institutions, as appropriate.

10. Provides regulatory assessments to internal local and global business partners regarding quality changes and artwork requirements.

11. Supports integration and re-organizations affecting organizational structures and/or product portfolio as appropriate.

12. Contribute to process improvements and participate in the creation of process descriptions, performs assessments on guidance’s (local/global SOP, WP, HA regulations) and the on-boarding process for new colleagues.

13. Ensure proper handling of deviations and CAPA handling regarding RA related compliance issues.

14. Monitors national changes by continuing education related to regulatory issues, which are likely to affect Novartis’ interests, and communicates these to local and global teams and management as appropriate.

15. Is obligated to report any Adverse Event or Technical Quality Complaint in accordance to the valid local SOPs.Minimum requirements“Kaufmännische Ausbildung” and 3-5 years of experience in the pharma industry and at least 2-3 years of relevant experience in a similar role OR Bachelor degree in the Life Sciences area

German and English (oral and written): Fluent

French and Italian are an assetDivisionGlobal Drug DevelopmentBusiness UnitREG AFFAIRS GDDLocationSwitzerlandSiteRotkreuzCompany/Legal EntityNovartis Pharma Schweiz AGFunctional AreaResearch & DevelopmentJob TypePart TimeEmployment TypeRegular

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