RIM Regulatory Specialist

Sé de los primeros solicitantes.
Solo para miembros registrados
Santiago de Compostela
EUR 40.000 - 60.000
Sé de los primeros solicitantes.
Hace 3 días
Descripción del empleo

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.

The Position

The Pharma Development Regulatory (PDR) and Pharma Technical Regulatory (PTR) organizations are responsible for developing and maintaining licenses for Roche's therapies, allowing them to be marketed globally. With around 1200 staff in key offices across six countries and representation in over 120 countries, the organizations manage a critical submission process within the Pharma value chain. Emphasizing reduced submission time and cost while maintaining high standards, the implementation of Veeva Regulatory Information Management (RIM) optimizes processes, data, and technology, enabling collaboration across PDR, PTR, and Drug Regulatory Affairs (DRA) affiliates.

As a RIM Regulatory Expert , you will play a key part in supporting the implementation of Veeva RIM technology across our affiliates worldwide.

The Opportunity :

Overseeing affiliate activities in the Regulatory Information Management System (RIM) for specific countries, ensuring tracking, publishing, and archiving.

Providing general support and troubleshooting daily activities for affiliates globally, including bundling submissions, data fixes, managing Technical Regulatory submissions, and preparing Submission Content Plans.

Acting as a Data & Content Analyst by monitoring and improving RIM data, collaborating with users to enhance data quality, providing guidance, training, system demonstrations, and resolving RIM SNOW tickets.

Providing input on future system enhancements and business process updates.

May be involved in collaborating with affiliates, PTR, PDR, and other functions to understand and improve business processes and learning needs.

May be involved in developing and updating guidance documents and job aids, and providing training for affiliates.

May be involved in training and onboarding agents in specific countries, in cooperation with affiliate and global teams.

Who You Are :

We are looking for a knowledgeable individual who is enthusiastic about new concepts and technology.

You have an understanding of regulatory frameworks and processes. Preferably with experience with Veeva RIM.

You have a systematic approach and strong attention to detail.

You are an excellent communicator in English, and able to simplify concepts and teach others.

You collaborate and work virtually with diverse teams across time zones, hierarchies, and cultures. Build and maintain productive and trusted relationships within the organization and with external partners.

You possess a continuous improvement mindset, actively seeking feedback on self and others, and identifying opportunities to streamline or improve processes, systems, and tools.

In exchange we provide you with :

Development opportunities : Roche is rich in learning resources. We provide constant development opportunities, free language courses & trainings, the possibility of international assignments, internal position changes and the chance to shape your own career.

Excellent benefits & flexibility : competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance : home office is a common practice (2 office days / week).

A global inclusive community , where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.

Data Privacy Notice for further information about how we handle your personal data related to the recruitment process :

Who we are

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.

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