Regulatory Project Manager Diagnostics
Roche · San José
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
Relocation benefits are not available for this job posting.
About this position: Owns products from a RA perspective for the assigned area of responsibility. Shall obtain Regulatory approvals in defined markets in close cooperation with other functions. The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines. The obtained Regulatory approvals/ permits/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls. The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc). The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization. The activities
are driven by a mindset of innovation, agility, and the principles of VACC leadership.
The Opportunity:
- Oversee complex regulatory document and submission compilation by applying a strong understanding of global regulatory challenges, internal processes and procedures, developing submission/product registration dossiers for more complex products, handling difficult assignments with broader expertise, and mentoring junior team members.
- Apply deep regulatory knowledge and strategy by understanding healthcare regulatory frameworks, maintaining compliance while accelerating innovation, managing complex issues, interpreting regulator thinking, tailoring strategies to different regional needs with limited guidance, and anticipating regulatory obstacles with mitigation or influencing strategies.
- Manage and influence stakeholders effectively by communicating and partnering to understand needs and deliver solutions, proactively addressing problems/opportunities, building enduring internal/external relationships that influence Roche’s direction, understanding external customer/stakeholder structures and responsibilities, supporting audits, and working effectively through influence without direct authority.
- Demonstrate VACC leadership, decision-making, and innovation by living “we all lead,” acting with integrity, courage, and passion, honoring commitments, supporting inclusion and diversity, fostering idea exchange, promoting vision, working with minimal/no supervision, developing and presenting solutions, making timely decisions, generating new ideas, leveraging diverse perspectives, and seeking new approaches.
- Solve problems and drive agile/digital improvement by troubleshooting issues, independently implementing cost-effective solutions without jeopardizing compliance, addressing highly complex problems, acting as a change ambassador, encouraging agile behaviors, improving processes across Q&R, embracing technologies, owning regulatory data, promoting data stewardship and regulatory tool usage, and contributing to/leading projects that connect business functions, systems, processes, and data toward digitalization and strategic goals.
- Strengthen communication, teamwork, and collaboration by making people feel heard, expressing complex ideas clearly, encouraging open discussions, providing truthful and honest input even in difficult situations, articulating multiple perspectives, speaking up, creating recognition/appreciation, uniting people around common goals, building on diverse perspectives, resolving conflict through openness and trust, and bringing out the best in people and teams.
Who you are:
- Bachelor’s/Master’s degree in Life Science, Data Science or related field, or equivalent experience through completed technician/laboratory technician training or comparable qualification.
- At least 5 years of experience (5–7 years preferred) in Regulatory, R&D, Quality, Operations and/or Clinical areas, with some experience in healthcare regulatory affairs.
- Able to manage more complex work and/or global projects; advanced degree is considered an advantage.
- Some business travel may be required.
Please note: Resumes must be submitted in English, as our interview panel may include participants from outside your local country.
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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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