Job Description Summary

Job Description

Job Description:

Sandoz continues to go through an exciting 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 Country Regulatory Affairs Specialist is responsible for the execution of specific Regulatory Affairs activities at Sandoz country level.

Tasks assigned will support in obtaining and maintaining the registered products, related texts and artworks, and (supporting) the execution of projects.

Duration:

Temporary maternity cover (at least 1 year engagement).

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Creation and translation of product information (PIL, SmPC, Labelling) and AW management

• Timely receipt of new Marketing Authorizations and their proper maintenance

• Updating regulatory databases

• Supports achieving the earliest acceptance of registration applications, launches and product site transfers.

• Provides regulatory support to the internal organization (e.g. Business Units and Portfolio & Launch, Medical)

• For the activities in scope of the role ensures that all relevant Key Performance Indicators (including safety label changes, artwork, checklists, deviations, RA input in RMP implementation and DHPC communication), are achieved timely and correctly

• Good and professional communication between internal and external stakeholders.

• Guarantees regulatory compliance for regulatory submissions and ensures adherence to Sandoz standards, and health authority legislation and expectations.

What you’ll bring to the role:

Essential Requirements:

• University Degree, Bachelor or Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.

• Preferably >1 year of relevant work experience in the pharmaceutical industry, Working in a highly regulated environment

• Fluent in Bulgarian and English language (spoken and written)

• Planning, organizational skills and eye for detail

• Strong written communication skills

• Data management and IT skills (MS Office package / SAP/ Veeva)

• Accountability for actions, setting own priorities and decision taking

• Result oriented

• High ethical standards

You’ll receive:

Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

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.

#Sandoz

Skills Desired