Regulatory Affairs Associate

Job Description

Summary The Country Regulatory Affairs Associate 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.

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 Associate is responsible for supporting the execution of specific Regulatory Affairs activities at Sandoz country level and supporting the RA team with administrative tasks. 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 1.5 year engagement). Your Key Responsibilities: Your responsibilities include, but not limited to:

• Supports in the timely creation & translation of 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 by (list is not exhaustive):
• 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.

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, preferably in the pharmaceutical industry
• Fluent in Bulgarian and English language (spoken and written)
• Planning, strong administrative organizational skills and eye for detail
• Data management and IT skills (MS Office package / SAP/ Veeva)

You’ll receive: In addition to a market-competitive base salary, we offer:

• An annual incentive program;
• Corporate car with permitted private use (fuel for personal trips covered by employee);
• Annual equity benefit with immediate share ownership;
• Learning and development options;
• Worldwide career opportunities.

Unleashing the potential of our people, we offer our corporate wellness program, which includes:

• Life insurance & Medical insurance for employee and children until age of 18;
• Sports monthly allowance;
• Up to 29 days of annual leave;
• Birthday allowance;
• Parental or maternity leave;
• Childcare monthly allowance;
• Flexible and remote working schedule.

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 Divers