Regulatory Affairs Associate 80% – 100% (d​/f​/m

Job Description Summary

See Job Description. Job Description Workplace:
Rotkreuz, Switzerland until 31 December 2027;
Basel, Switzerland as of 01 January 2028.

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The Regulatory Affairs Associate is responsible for supporting the execution of specific Regulatory Affairs activities at Sandoz country level. Plus, supporting the RA team with administrative tasks. Tasks assigned will support obtaining and maintaining the registered products, related texts and artworks, and (supporting) the execution of projects.

Your responsibilities include, but are not limited to:

• Compliance:
  Guarantees adherence to the relevant (local) procedures, and record management.
• Supports RA during internal and external audits and health authority inspections at country level.
• Activities to support Sandoz and our customers:
  Supports in the timely creation & translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks).
• Supports in the maintenance of registration files.

This is done by (non-limitative list):

• Supports administrative activities.
• Registration maintenance activities, product related text translations (checks).
• Answering questions from local health authorities regarding registered products.
• Artwork management from change to approved new/revised artwork.
• Updating regulatory databases and plans.
• Local regulatory tasks related to Risk Management Plan (RMP) / Risk Minimization Activities (RMA) and Dear Healthcare Professional Communications (DHPC) (as per global SOP).
• Supports in timely preparing the payment of regulatory fees and related administrative activities.
• Supports RA database maintenance activities, timely KPI preparation and reporting.
• Can be responsible for creation and follow‑up of purchase orders, proof‑of‑payments, and other RA fees for the RA team.
• Archiving of RA related documentation (paper and/or electronic archive maintenance).
• Guarantee good and professional communication between internal and external stakeholders.
• Support (local) RA projects.

Country specific additional activities (if needed):

• Participates in Product Cross Functional Teams as required.
• Provide close regulatory support to internal local stakeholders, as well as other Global Regulatory Teams.
• Check Swiss medic updates and follow trends in the regulatory environment and legislation, assure awareness and alignment within the department, to meet future requirements on time.
• Support signal notification to Swiss medic.
• Support Pharmacovigilance activities.

Essential and Desirable Requirements:

• Either a bachelor in Bio-Medical / Life Sciences / Pharmaceutical sciences or a professional administrative degree.
• Preferably >1 year of relevant work experience.
• German (fluent: verbal and written), English (fluent: verbal and written) French (desirable) and Italian (desirable).
• Experience of working in a highly regulated environment.
• Planning, organizational skills and eye for detail.
• Strong administrative organization skills.
• Strong written communication skills.
• Data management and IT skills (MS Office package / SAP).

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is…