Regulatory Affairs Partner
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.