Regulatory Affairs Partner — Accelerate Global Approvals

F. Hoffmann-La Roche AG; Fatih; On-site; TRY 350,000 - 550,000; Full time

Job summary

Roche is seeking a Regulatory Affairs professional in Turkey to develop regulatory strategies for new products and indications, adapt global dossiers to local requirements, and manage submission timelines to enable fast market access.

You will coordinate GMP/registration submissions, support launch planning, document regulatory processes, ensure inspection readiness, and collaborate with cross-functional teams and health authorities to ensure compliant, timely access to Roche medicines and

Qualifications

• Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, or related field.
• Minimum 3 years of experience in regulatory affairs.
• Hands-on knowledge of regulatory processes and requirements.
• Experience coordinating or supporting project activities within a team.

Responsibilities

• Develop innovative regulatory strategies for Roche's new products and indications.
• Define regulatory submission timelines, and plan launch dates accordingly.
• Manage GMP, prioritization, and registration submissions for innovative products.
• Adapt global product dossiers to meet local regulatory requirements; gather and prepare additional documentation as needed.
• Design and implement policy initiatives to shape the Turkish regulatory environment in alignment with Roche's strategy.
• Ensure inspection-readiness for GMP and regulatory audits; manage related processes within relevant systems.
• Collaborate closely with cross-functional teams for the launch planning of new products or indications.
• Engage in effective advocacy activities with health authorities, industry associations, and key stakeholders.
• Conduct the necessary correspondence for all registered/non-registered products and follow up with the Ministry processes

Skills

Regulatory affairs

Cross-functional collaboration

Project coordination

Team leadership

Education

Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, or related field

Job description

Roche is seeking a Regulatory Affairs professional in Turkey to develop regulatory strategies for new products and indications, adapt global dossiers to local requirements, and manage submission timelines to enable fast market access.

You will coordinate GMP/registration submissions, support launch planning, document regulatory processes, ensure inspection readiness, and collaborate with cross-functional teams and health authorities to ensure compliant, timely access to Roche medicines and