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.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The PD Regulatory Program Management Chapter is committed to providing comprehensive global regulatory strategies and leading all aspects of the end-to-end execution of clinical projects within the Roche portfolio, with the goal of developing and maintaining product permits/licenses to serve patient needs. Members of this chapter are tasked with leading the regulatory components of clinical development and registration programs for products, both pre- and post-licensing. This is achieved through the creation of innovative and effective global regulatory strategies, assessments, plans, and supporting documentation. These efforts are made in collaboration with regional regulatory affairs counterparts, cross-functional product teams, corporate partners, and global health authorities, demonstrating up-to-the-minute regulatory knowledge and expertise.
Internally this role is known as a Regulatory Program Management Professional / Specialist - Labeling.
The Opportunity
* Contribute to the global product team in crafting and maintaining the company Core Data Sheet (CDS), core Patient Product Information (cPPI), and key local product labels for the EU and US throughout the lifecycle of pharmaceutical products and devices, ensuring compliance with labeling requirements.
* Apply critical thinking and effective data messaging in the creation and maintenance of regulatory labeling documents, ensuring clarity and accuracy in product information.
* Lead or contribute to company documents and responses to Health Authority requests related to product labeling, facilitating clear communication and compliance with regulatory standards.
* Guide the product team and country affiliates in the implementation of CDS updates to local labels, ensuring consistency and adherence to global regulatory requirements.
* Partner with key stakeholders, work on the molecule portfolio, and contribute to key initiatives that shape Roche's technical, business, and healthcare environments, ensuring alignment with organizational goals and innovative solutions.
* Maintain Roche's License to Operate by ensuring all labeling activities adhere to regulatory requirements and corporate policies, including medical compliance and adherence to the Roche Group Code of Conduct.
* Keep informed about internal and external developments, trends, and the competitive landscape relevant to Roche/Genentech products, allowing for proactive and informed regulatory decision-making.
* Contribute to the development and implementation of new or updated PDR and PDRL-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, and processes crucial for content creation and tracking, ensuring end-to-end labeling compliance.
Who you are
* You have a bachelor's degree with solid proven experience in current therapeutic area focus in PD Regulatory Program Management
* You understand and demonstrate your own expertise while developing insight into the external regulatory environment.
* Apply creative thinking to contribute to documents, strategic proposals, and a broader range of results. Recognise the impact of contributions to the PD Regulatory Chapter and actively share insights and knowledge to improve team performance.
* Establish trustful and open relationships with key stakeholders, collaborate effectively to deliver specific PD Regulatory deliverables, and seek different perspectives to evolve ideas.
* Approach work with curiosity, adapt to change, and proactively seek learning opportunities. Understand the importance of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) principles and data integrity, ensuring high standards are maintained in all regulatory activities while applying PDR advice-seeking principles to informed decision-making processes.
This role is based onsite at either our Welwyn, United Kingdom or Mississauga, Canada offices. Please upload only your current compelling CV and / or Cover Letter.
We look forward to receiving your application!
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.
Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.
Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.