Regulatory Program Director

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

Technical Regulatory at Roche plays a key role in the process of developing new medicines and making them available to patients world-wide. We provide the strategy, expertise, and guidance to ensure world-class technical regulatory support for the chemistry, manufacturing, and controls (CMC) section of clinical trial licensure applications, new market applications, and post-approval changes. We are part of internal development and marketed product teams and collaborate with health authorities and industry groups world-wide.

The Opportunity:

We are looking to fill the Regulatory Program Director position in the Pharma Technical Regulatory (PTR) department with focus on biologics, experience in synthetic molecules is a plus.

• Development, communication, and implementation of the technical regulatory strategy, considering the entire product lifecycle, applying deep regulatory knowledge and critical thinking

• Responsible for submitting high-quality CMC regulatory documents to health authorities worldwide in accordance with current GMP standards and Roche corporate guidelines

• Ensuring compliance and accuracy of data in regulatory documents and information management systems

• Coordinating and leading interactions with health authorities, as well as representing Technical Regulatory in cross-functional teams

• Developing regulatory strategies to ensure timely approval of Roche products and supporting the team in achieving successful regulatory outcomes

• Contributing to regulatory excellence by identifying opportunities, mitigating risks, and supporting continuous improvement to optimize regulatory processes and efficiency

Who You Are:

You bring the following:

• Hold a Master's degree in a scientific field (advanced degrees are a plus) and have extensive experience in CMC regulatory affairs within the pharmaceutical industries, with a focus on CMC, quality, or related fields

• Experience in working with biologics across various lifecycle stages is preferred; knowledge of other modalities like synthetic molecules or device/combination products is an advantage

• Strong understanding of global, international, and local regulatory strategies and policies, with the ability to define and influence technical regulatory strategies

• Skilled in collaborating with cross-functional teams to drive lifecycle simplification and deliver high-impact outcomes for the organization

• Demonstrate a proactive approach in prioritizing tasks, challenging the status quo, and driving innovation while maintaining a focus on value-driven deliverables

• Passionate about digital evolution, proficient in handling and transforming structured and unstructured data, and able to use creativity and decisiveness to solve problems and drive progress in projects

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

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.