Regulatory Affairs Partner

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Key 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

Who You Are:

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field
• Minimum 3 years of experience in regulatory affairs, ideally working in cross-functional settings
• Hands-on knowledge and solid understanding of regulatory processes and requirements
• Preferably, some experience in coordinating or supporting project activities within a team environment
• A collaborative mindset with the ability to motivate colleagues and contribute to team development
• Willingness and capability to share knowledge, provide support, and offer guidance within the team when needed
• Strong communication skills and a team-oriented approach
• High ethical standards and a basic understanding of relevant compliance regulations
• Proficiency in both written and spoken Turkish and English
• Comfortable working in a dynamic, agile environment; open to change, self-motivated, responsible, and eager to learn

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.