The Position

Join our exciting team and help Roche bring new medicines to the patients!

Job Mission

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.

We are looking to fill a technical regulatory affairs manager position in the Pharma Technical Regulatory (PTR) department. Our department is currently adopting agile ways of working with the objective of increasing speed, efficiency, knowledge sharing and flexibility. Therefore, the role may cover both synthetic molecules and biologics, development, and marketed products projects upon demand.

The position can either be located at Mannheim or Penzberg (Germany) or Basel (Switzerland).

Your Impact

• Being accountable for the development, communication and implementation of regulatory strategies that anticipate and address challenges throughout the product lifecycle by applying profound knowledge, regulatory intelligence, innovation, science-driven risk-based approaches and critical thinking.

• Being responsible for submissions of high-quality CMC regulatory documents to health authorities in accordance with Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.

• Being responsible for the execution of submission-related and administrative activities for global technical registrations as well as maintenance of CMC documentation in internal document management systems.

• Effectively managing regulatory changes throughout the product life cycle.

• Coordinating and/or leading health authority interactions for assigned projects and representing Technical Regulatory at multidisciplinary meetings with health authorities.

• Representing PTR on other cross-functional teams and working with diverse partners and personalities.

• Contributing to excellence by finding opportunities, mitigating risks, and supporting continuous improvement.

• Being accountable to keep abreast of regulatory procedures and changes.

• Recommending strategies for earliest possible approvals of clinical trial applications, initial marketing applications and/or post-approval changes.

• Contributing to driving efficiency by assertively simplifying, trying new ways, and cutting out waste.

Who You Are

• Have a Bachelor’s degree - preferably in a scientific field; an advanced degree is a plus.

• Have a broad work experience in CMC regulatory affairs in the pharmaceutical industry or an in-depth work experience in the pharmaceutical, biotechnology or related industry, CMC, quality or related experience.

• Able to share complex concepts with simple and clear language and adapt messaging for stakeholder understanding.

• Being capable of working in the CMC regulatory area for synthetic molecules / large molecules in different lifecycle stages is preferred; other modalities like device/combination products are an advantage.

• Able to collaborate efficiently with other partners to drive and enable overall life cycle simplification for all functions involved.

• Capable of prioritizing and working effectively both within a team environment and independently.

• Able to influence teams and functions in defining global technical regulatory strategies as well as to share a vision and inspire others to make this vision a reality.

• Being open, curious and willing to experiment with agile ways of working.

• Being comfortable with challenging the status quo, taking risks, experimentation, and ambiguity.

• Able to work with different types of data (structured and unstructured) and prepare, transform and connect/separate levels of data to gain the best information out of it.

• Being passionate about digital evolution and handling data on a daily basis in IT systems.

• Taking ownership, being decisive, and using your knowledge, network, and creativity to solve problems and progress programs and projects.

Who we are

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.