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.

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.

As Regulatory Program Specialist your responsibilities may include a wide variety of contributions, like partnering with key stakeholders, working on the molecule portfolio, collaboration with affiliates and partnering with the Policy team to influence HAs or contributing to key initiatives that shape our technical business and healthcare environments.

Your Opportunity
The responsibilities for this role include:

• Accountable for global planning, tracking, and monitoring of certain regulatory information, which is required for external/internal compliance and execution of submissions.
• Participate in the developing and implementing the strategy for configuring submission data in a regulatory information management system. Manages regulatory information activities alongside the regulatory product portfolio team.
• Provide input on future system enhancements, business process updates, and submission model documents.
• May manage/report regulatory data across multiple regional functions including internal stakeholders at other Roche sites and vendors.
• Act as a Business Process Owner and/or Subject Matter Expert for specific Regulatory information activities and technologies, including developing process documentation and delivering training, as needed.
• Partner with PT, PD, p RED and g RED to align and implement a single Regulatory data strategy including how data is monitored, evaluated, and how it flows within our systems environment.

Who you are

The person in this role is able to build and maintain productive and positive relationships within/across departments as well as with external partners and regulators. Understands and applies in-depth knowledge of Roche and regulatory guidelines, procedures and processes.
Performs system searches, prepares and analyzes sophisticated reports, and coordinates assembly of documentation to support Stakeholders.

• Experience in regulatory affairs, with similar roles, with a good understanding of the regulatory strategy and processes, thinking creatively. Has an ability to understand and adapt to change, and proactively seeks opportunities to learn and practice new skills.
• Stays abreast of new developments and understands required laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Drives awareness of the regulations.
• Advanced English proficiency is required

Relocation benefits are not available for this job posting.
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.

The Roche Services & Solutions as well as People Support Solutions organisations located in San Jose provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the Americas region. Today Roche employs altogether around 800 employees in Costa Rica.