Strategic Regulatory Affairs Partner for Market Access

Biopharma Careers; Fatih; On-site; TRY 90,000 - 130,000; Full time

Job summary

Roche in Turkey is seeking a regulatory affairs specialist to shape regulatory strategies for new products and indications, and to adapt global dossiers to local requirements. You will define submission timelines, manage GMP and registration submissions, and coordinate with cross-functional teams to enable rapid market access.

You will engage with health authorities and industry groups, ensuring inspections readiness and compliance while supporting launch activities in a dynamic, agile

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field.
• Minimum 3 years of experience in regulatory affairs, ideally in cross-functional settings.
• Hands-on knowledge and solid understanding of regulatory processes and requirements.

Responsibilities

• Develop innovative regulatory strategies for Roche’s new products and indications to enable fast market access.
• Define regulatory submission and approval 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 strategy

Regulatory affairs

Cross-functional collaboration

Communication skills

Turkish and English proficiency

Education

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

Job description

Roche in Turkey is seeking a regulatory affairs specialist to shape regulatory strategies for new products and indications, and to adapt global dossiers to local requirements. You will define submission timelines, manage GMP and registration submissions, and coordinate with cross-functional teams to enable rapid market access.

You will engage with health authorities and industry groups, ensuring inspections readiness and compliance while supporting launch activities in a dynamic, agile