Regulatory Strategy Partner (Global & Turkey)

Roche; Fatih; On-site; TRY 180,000 - 320,000; Full time

Job summary

Roche in Turkey seeks a Regulatory Affairs professional to lead strategies for new products and indications, enabling fast market access and compliant launches. You will coordinate submission timelines, adapt global dossiers to local requirements, and ensure GMP and audits readiness, working closely with cross-functional teams and health authorities.

Turkish and English fluency is required, with a collaborative mindset.

Qualifications

• Solid knowledge of regulatory processes and requirements.
• Experience in cross-functional project settings.
• Willingness to share knowledge within the team.
• Strong communication and team orientation.

Responsibilities

• Develop regulatory strategies for Roche's new products and indications.
• Define submission timelines and plan launch dates.
• Manage GMP, prioritization, and registration submissions.
• Adapt global dossiers to local regulatory requirements.
• Design policy initiatives to shape Turkish regulations.
• Ensure GMP/regulatory audit readiness.
• Collaborate with cross-functional teams for launch planning.
• Engage with health authorities and industry groups.
• Handle correspondence for registered and unregistered products with the Ministry.

Skills

Regulatory strategy

GMP knowledge

Cross-functional teamwork

Turkish language

English language

Project coordination

Compliance awareness

Education

Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry

Job description

Roche in Turkey seeks a Regulatory Affairs professional to lead strategies for new products and indications, enabling fast market access and compliant launches. You will coordinate submission timelines, adapt global dossiers to local requirements, and ensure GMP and audits readiness, working closely with cross-functional teams and health authorities.

Turkish and English fluency is required, with a collaborative mindset.