Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

And as the world evolves, so do we. For over 125 years, we have tackled some of the most sophisticated challenges in healthcare.

Are you eager to join a team dedicated to bringing new medicines to patients? Roche is seeking a (Senior) Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department.

At Roche, Technical Regulatory plays a crucial role in developing new medicines and making them accessible worldwide. We provide strategy, expertise, and mentorship to offer top-tier technical regulatory support for the chemistry, manufacturing, and controls (CMC) components of clinical trial licensure applications, new market applications, and post-approval changes. We collaborate with health authorities and industry groups globally and are integral to our internal development and marketed product teams.

The Opportunity:

You support different types of modalities (small molecules, oligonucleotides, peptides) and product life-cycles with a focus on peptides

Develop, communicate and implement robust regulatory strategies that align with global regulatory requirements

Identify and communicate regulatory risks; develop and implement risk mitigation strategies in collaboration with technical functions

You are responsible for authoring, reviewing and/ or submission of high-quality CMC regulatory documents to health authorities

You represent PTR on cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs) and work with diverse partners and personalities

Who you are:

Bachelor’s degree in a scientific field, preferably; advanced degree highly desirable

Confirmed experience in CMC regulatory submissions and strategy in different lifecycle stages, ideally including peptides 

Effective matrix leadership skills, an agile strategic approach, and strong communication abilities

Ability to lead, handle and communicate sophisticated CMC issues efficiently

Demonstrated experience in successfully guiding complex global regulatory strategies and effectively managing high-stakes regulatory interactions with health authorities

Comfortable taking measured risks, experimenting with new insights, and navigating ambiguity

Join us in our mission to improve global health - apply your expertise and passion to make a real difference. We offer a collaborative and inclusive environment where you can thrive and grow.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.