Regulatory Affairs Associate (d/f/m)

Job Description Summary

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 andpersonally. Joinus,the future is ours to shape!

The Regulatory Affairs Associateis responsible forsupporting the execution of specific Regulatory Affairs activities at Sandoz country level.Plus,supporting the RA team with administrative tasks.Tasks assigned willsupportobtaining andmaintainingtheregisteredproducts, relatedtextsand artworks, and (supporting) the execution of projects.

Your Key Responsibilities:

Your responsibilities include,butarenot 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 thetimelycreation & 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 authoritiesregardingregistered 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 intimelypreparing the payment of regulatory fees and related administrative activities.

• Supports RA database maintenance activities,timelyKPI preparation and reporting. Canbe responsible forcreation 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 specificadditionalactivities (if needed):

• Participates in Product Cross Functional Teams asrequired.

• 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.

Whatyou’llbring to the role:

Essentialand DesirableRequirements:

• Either a bachelor in Bio-Medical / Life Sciences / Pharmaceuticalsciencesor 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 humanrightof good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, wehave the opportunity toshape 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 diverseteamsrepresentative ofthe 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 [email protected] 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