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.
In this Leadership position in Pharma Technical Regulatory (PTR) you will have a broad understanding of the regulatory landscape and apply your knowledge in the execution of deliverables aligned with our North Star. As a leader you are accountable for advocating and driving changes throughout the organization and supporting our people in a global environment. You will have a thorough understanding of priorities and areas of high impact, connect the right people and resources with the right work and help the organization adapt to evolving regulatory requirements. You will inspire all of our people to boldly innovate, collaborate and create outcomes that matter for patients, stakeholders and the company.
In the role of a Regulatory Group Director you will oversee both Portfolio and People Leadership supporting / enabling teams and people within this operating model (PTR ecosystem) to deliver on overall business objectives.
You will have oversight and will be accountable for the development and implementation of end to end regulatory strategies and initiatives on a portfolio level.
You will define strategies for a specific portfolio (e.g. portfolio of products within a modality, cross-functional initiatives targeting innovation, operational excellence, policy) and translating into outcome and outputs, ensuring transparency across squads and teams, prioritization, driving resource planning and budgeting, and developing a long-term vision
You will work collaboratively at the global level, with other leaders to align on priorities and support the achievement of the organizational goals by contributing to support the projects and initiatives on an as needed basis.
You will stay abreast of internal and external developments and trends to maintain a current perspective of implications for all programs. Drive internal and external awareness of the implications.
You will lead health authority interactions and submission reviews for assigned projects with an expanded scope; representing Technical Regulatory at multidisciplinary meetings with health authorities. In addition you will be a key point of contact for one (or more) regulatory capability area(s) (e.g. CTA, NDA, LCM, data management, systems) and drive efficiency and excellence in this area.
You will serve as the voice of the organization and ensure that challenges, opportunities and initiatives / actions taken by the leadership and enabling teams are communicated to the employees in a meaningful, systematic and thoughtful manner. In addition you will build and maintain relationships with key internal stakeholders. anticipate and remove organizational barriers that impede forward action and progress.
As a leader you will enable self-managed teams by being visionary, and an architect, coach and catalyst to the organization and be responsible for performance management of direct reports. You will ensure that objective and timely feedback is provided to employees and focus on the development of the employees by facilitating regular development discussions and check-ins.
You will bring excellent communication and presentation skills and be able to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.
Furthermore, you bring the below qualifications and experience:
Bachelor’s degree, with a strong preference for scientific focus or equivalent industry experience. Master’s Degree in life science disciplines is strongly preferred; Post Graduate Degree is a plus.
10 or more years of work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory, or related experience. Ideally including people leadership experience.
Proven knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities. In addition you would have solid experience developing regulatory strategies and scenario planning with robust regulatory risk assessment.
Strong technical understanding of drug substance and product manufacturing, in one or both modalities Synthetic Molecule and LM and product development processes, as appropriate.
Understanding of drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.
Proven track record of team leadership, preferably cross-functional teams and ability to develop people through coaching
Previous People management or cross-functional team leadership experience is desired
Do you find yourself in this role, does this read like you? Then, please apply now! We are looking forward to receiving your application!
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.