Regulatory Affairs Partner

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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.