# Regulatory Affairs Partner at Roche

Roche is hiring a Regulatory Affairs Partner. Level rates it Little AI ●○○○; you can [apply on Roche](https://jobsbylevel.com/go/02a7d663-1353-41b4-82a5-d63cc34ef799?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Sarajevo.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Sarajevo
- Posted: October 22, 2026
- Apply: https://jobsbylevel.com/go/02a7d663-1353-41b4-82a5-d63cc34ef799?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=regulatory-affairs-partner-at-roche-b8010b

## Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The Regulatory Affairs Partner is responsible for overseeing and maintaining compliance with all regulatory requirements and standards for commercially available products of Roche in Bosnia and Herzegovina. The role holds primary responsibility and perform tasks for: License to Operate & Batch Release: Act as the designated person responsible for marketing of the medicinal product and for quality control of each imported batch (batch release) in Bosnia and Herzegovina. Ensure timely quality control and release of each batch of F. Hoffmann-La Roche medicinal products imported into the market of Bosnia and Herzegovina. Regulatory Lifecycle Management & Compliance: Ensure timely registration and obtaining of marketing authorizations for Roche products in Bosnia and Herzegovina, aiming to ensure rapid expansion of the product portfolio and adequate market availability (focus on maintenance of marketing authorizations: renewals and variations/changes). Ensure timely execution of all activities pertaining to the submission of regulatory documentation for Roche products. Adapt global product dossiers to local regulatory requirements. Ensure harmonization of regulatory documentation with commercial and supply chain needs to ensure business continuity. Ensure regulatory compliance for products placed on the market in accordance with approved marketing authorizations, including local packaging and labeling specifications. Inspection Readiness & Regulatory Systems: Ensure the affiliate’s readiness for regulatory inspections, including leading or participating in internal/external regulatory audits. Ensure all regulatory activities of the affiliate align with Roche global standards and local regulations. Ensure accurate, timely, and thorough data entry for the affiliate’s regulatory activities into relevant Roche global systems. Develop and maintain up-to-date knowledge of international and local regulations, as well as leading regulatory practices, policies, procedures, systems, and standards. Cross-Functional & External Partnering: Maintain active communication with internal and external stakeholders (e.g., Agency for Medicinal Products and Medical Devices of BiH - ALMBiH) to achieve successful regulatory outcomes. Review and approve promotional materials to provide appropriate regulatory input across the entire affiliate. Provide support to local market access activities from a regulatory perspective. Ensure availability of data regarding the registration status of competitors’ products when necessary. Who You Are Education: University degree in Pharmacy (Master's / Bachelor’s degree - Magistar farmacije ). Licensure: Passed National Professional Board Exam in BiH ( Stručni ispit ). Experience: Proven (3+ years) of professional experience in the pharmaceutical industry, specifically in the field of regulatory affairs and local batch release procedures with ALMBiH. Skills & Knowledge Knowledge, affinity, and proficiency in Regulatory Affairs and regulatory frameworks in BiH. Knowledge, affinity, and proficiency in Regulatory systems (e.g., RIM-Veeva Vault, e-portal ALMBiH). Clear understanding of applicable local pharmaceutical regulations, international regulatory standards, and quality requirements for batch release. Strong communication skills with all levels of internal and external organization stakeholders. Language Fluency: Mandatory proficiency in English and local languages (Bosnian/Croatian/Serbian), both written and spoken. Capabilities, Mindsets & Behaviors

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/regulatory-affairs-partner-at-roche-b8010b

Source: https://jobsbylevel.com/jobs/regulatory-affairs-partner-at-roche-b8010b

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