Regulatory Affairs Associate (d/f/m)

C115 (FCRS = CH115) Sandoz Pharmaceuticals AG; Rotkreuz; On-site; CHF 70,000 - 95,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs professional to support local regulatory activities at Rotkreuz, Switzerland, with relocation to Basel from 01 January 2028. The role involves ensuring adherence to procedures, assisting audits, and maintaining registration files across biosimilar and generic medicines landscapes.

Ideal candidates have a relevant degree, 1+ year experience, and strong German/English language skills; French/Italian are desirable. MS Office and SAP proficiency is expected.

Qualifications

• Bachelor degree or equivalent in related field.
• 1+ year of relevant work experience preferred.
• Fluent German and English; French/Italian desirable.
• Experience in a highly regulated environment.
• Strong planning, organization and attention to detail.
• Strong written communication skills.
• Data management and IT skills (MS Office, SAP).

Responsibilities

• Ensure adherence to local procedures and maintain records.
• Support regulatory activities during audits and health authority inspections.
• Assist in creation and translation of official product information including SmPCs and labeling.
• Maintain registration files and regulatory databases.
• Support administrative activities and KPI reporting.
• Coordinate regulatory tasks related to RMP/RMA and DHPC.
• Support RA projects and cross-functional regulatory initiatives.

Skills

German (fluent)

English (fluent)

French (desirable)

Italian (desirable)

Education

Bachelor in Bio-Medical / Life Sciences / Pharmaceutical sciences or admin degree

Tools

MS Office

SAP

Job description

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!

Your Key Responsibilities

• Guarantees adherence to the relevant (local) procedures, and record management.
• Supports RA during internal and external audits and health authority inspections at country level.
• 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.
• 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.
• Participates in Product Cross Functional Teams as required.
• Provide close regulatory support to internal local stakeholders, as well as other Global Regulatory Teams.
• Check Swissmedic 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 Swissmedic.
• 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).

Why Sandoz?

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 powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e‑mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

#Sandoz Skills Desired Data Analysis, Documentation Management, Operational Excellence

Our Purpose

Here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more!

Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!