Regulatory Affairs Associate (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 Key Responsibilities:

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 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.

What   you’ll   bring to the role:

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  [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

Data Analysis, Documentation Management, Operational Excellence