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.

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

Borderless Collaboration: Working closely and effectively with other countries, communities, and cross-functional teams.

Stakeholder Management: Ability to build strong, collaborative relationships with regulatory authorities, internal partners, and external stakeholders.

Strategic Capabilities & Risk Management: Proven strategic capabilities, organizational awareness, and proactive planning with an embedded risk management mindset.

Proactive & Growth Mindset: Growth mindset, problem-solving skills, and excitement about continuous learning through experience.

Living Roche Values: Demonstrated ability to live Roche Values, Leadership Commitments, VACC (Visionary, Architect, Coach, Catalyst) leadership, and Operating Principles.

Please submit your CV in English.

The deadline to apply is by: 29 October midnight.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.