Regulatory Affairs Project Manager; m​/w​/d - befristet

Position: Regulatory Affairs Project Manager (m/w/d) - 15 Monate befristet
Location: Germany

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*- for German version please see below
- * At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As Global Quality & Regulatory in the Roche Diagnostics Division, we are a global team engaged across the diagnostic value chain, ensuring our right to operate, shaping the global regulatory environment, and accelerating access to our diagnostic solutions for customers and patients.##

Job Role We are looking for a proactive Regulatory professional in our Companion Diagnostics (CDx) Chapter in Global Regulatory Affairs for our Core Lab Non-Oncology Sub-Chapter. You will be leading product approvals and lifecycle management through strategic coordination and seamless cross-functional collaboration. You will ensure the timely delivery of submission-ready documentation while maintaining global compliance and navigating complex regulatory landscapes with agility.

By championing an innovative mindset and VACC leadership principles, you will transform regulatory requirements into transparent, actionable strategies that drive our mission forward.## The Opportunity
* You will lead the development and oversight of complex submission dossiers, ensuring global product registrations are executed accurately while sharing experience to enhance team expertise
* You will navigate intricate healthcare regulatory frameworks to design innovative strategies that anticipate obstacles and accelerate product access for patients across diverse regions.
* You will be in charge of building influential, enduring relationships with both internal partners and external stakeholders, ensuring regulatory needs are communicated effectively and integrated into the company's future direction.
* You will champion the VACC leadership spirit by fostering an inclusive environment, proactively persuading others across functional boundaries, and driving a vision of integrity and courageous decision-making.
* You will take care of complex problem-solving and process innovation, working independently to troubleshoot issues and implement logical, cost-effective solutions that maintain strict compliance.## Who You Are
* Educational Background:
You hold a Bachelor’s or Master’s degree in Life Science, Data Science, or a related field. Alternatively, you have completed professional training as a technician or laboratory technician with equivalent practical qualification and experience relevant to the role's tasks.
* Professional

Experience:

You bring a minimum of 5 years of professional experience within Regulatory Affairs, R&D, Quality, Operations, and/or Clinical environments.
* Regulatory Expertise:
You possess foundational experience in Healthcare Regulatory Affairs and demonstrate a deep understanding of the complexities inherent in a global regulatory landscape  (Track Record in IVD Regulatory or Pharma Regulatory is a plus).
* Project Management & Complexity:
You are proven in managing high-complexity workflows and/or global projects. You have the ability to work independently, make logical decisions under minimal supervision, and drive results in a fast-paced environment.
* Communication

Skills:

You are business fluent in English (written and spoken), enabling you to negotiate and communicate effectively within a global organization and with external stakeholders.
* Strategic Mindset:
You excel at interpreting regulatory frameworks to accelerate innovation. You are a self-motivated…