Regulatory Affairs Partner

About the role

Roche is looking for a Regulatory Affairs Partner in Sarajevo, Bosnia and Herzegovina. The role oversees and maintains compliance with all regulatory requirements and standards for commercially available Roche products in the country, covering license to operate, batch release, marketing authorization and inspection readiness.

Key responsibilities

• Act as the designated person responsible for marketing of the medicinal product and quality control of each imported batch (batch release).
• Ensure timely registration and marketing authorizations, including renewals and variations, and adapt global product dossiers to local requirements.
• Submit regulatory documentation on time and keep regulatory documentation aligned with commercial and supply chain needs.
• Ensure compliance with approved marketing authorizations, including local packaging and labeling.
• Prepare the affiliate for regulatory inspections and audits, and keep regulatory activities aligned with Roche global standards and local regulations.
• Maintain accurate data entry in Roche global systems and stay up to date on international and local regulations.
• Communicate with internal and external stakeholders, including the Agency for Medicinal Products and Medical Devices of BiH (ALMBiH), review and approve promotional materials, and support local market access.

Required profile

• University degree in Pharmacy (Master's or Bachelor's, Magistar farmacije).
• Passed the National Professional Board Exam in BiH.
• 3+ years of professional experience in the pharmaceutical industry, in regulatory affairs and local batch release procedures with ALMBiH.
• Fluency in English and in Bosnian, Croatian and Serbian, written and spoken.

Required skills

• Knowledge of regulatory affairs and regulatory frameworks in BiH.
• Proficiency in regulatory systems such as RIM-Veeva Vault and the ALMBiH e-portal.
• Strong communication skills with internal and external stakeholders.