Regulatory Compliance - Project Management
Roche · Sant Cugat del Vallès, Catalonia, Spain
- On site
- Full-time
- €85,000 / year
- Sant Cugat del Vallès, Catalonia, Spain
Job highlights
- Lead regulatory interpretation and compliance projects.
- Assess product impact on environmental regulations.
- Develop strategic compliance roadmaps.
- Drive cross-functional implementation of regulatory opinions.
- Serve as internal technical expert on compliance.
About the role
About Roche and Our Culture
At Roche, we celebrate individuality and value the unique qualities each person brings. Our culture fosters personal expression, open dialogue, and genuine connections. We ensure you are valued, accepted, and respected, allowing you to thrive both personally and professionally. Our mission is to prevent, stop, and cure diseases and ensure global access to healthcare for present and future generations. Join Roche, where every voice matters.
The Position: Regulatory Compliance Project Manager
As a Project Manager/Regulatory SME (Subject Matter Expert) within the Center of Excellence, you will bridge the gap between regulatory requirements and technical implementation. You will guide the organization in interpreting environmental product regulations such as Biocides, RoHS, F-Gas, and others, ensuring Roche Diagnostics products are managed compliantly worldwide. Your role involves driving projects to define compliance standards for our product portfolio, both currently and in the future.
Your Key Responsibilities
- Detailed Regulatory Assessment: Lead the technical evaluation of new and evolving regulations.
- Translate complex legal texts into a clear, auditable 'Regulatory Opinion'.
- Product Impact Analysis: Use your scientific background to assess impacts of chemical compositions and product designs on hazard communication standards.
- Strategic Compliance Roadmap: Identify emerging regulatory trends and define long-term strategies to future-proof the Roche product portfolio.
- Cross-Functional Implementation: Drive implementation projects across all levels, ensuring operational teams (OETs), operations, and R&D understand and apply regulatory opinions to compliance outputs.
- Internal Point of Contact: Serve as the primary technical expert for internal inquiries, prioritizing work based on risk and business impact.
Who You Are
- The Scientist-turned-Regulator: You possess a University degree and experience in Product Stewardship/Product Environmental Regulations.
- The Analytical Thinker: You excel at dissecting legal texts and applying them to technical product data.
- The Effective Communicator: You can articulate regulatory rationale to both scientific and business stakeholders.
- The Collaborative Partner: You thrive in a global 'Center of Excellence' environment, collaborating with Monitoring squads and Operational teams.
Location and Compensation
Pay transparency applies to this role, with details provided based on the primary posting location. The primary location for this position is Sant Cugat del Vallès. If you are interested in other potential locations, compensation details will be shared later in the hiring process.
About Roche
A healthier future inspires our innovation. With over 100,000 employees globally, we are dedicated to advancing science and ensuring healthcare access for all, today and for generations to come. Our work impacts over 26 million people treated with our medicines and over 30 billion tests conducted with our Diagnostics products. We foster an environment that encourages exploration, creativity, and high ambitions to deliver life-changing healthcare solutions with global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Key skills/competency
- Regulatory Compliance
- Project Management
- Product Stewardship
- Environmental Regulations
- RoHS
- F-Gas
- Biocides
- Hazard Communication
- Technical Evaluation
- Cross-Functional Implementation
Skills & topics
- Regulatory Compliance
- Project Management
- Product Stewardship
- Environmental Regulations
- Biocides
- RoHS
- F-Gas
- Hazard Communication
- Roche
- Diagnostics
How to get hired
- Tailor your resume: Highlight experience with product stewardship and environmental regulations like RoHS, F-Gas, and Biocides. Emphasize project management skills and your ability to translate legal text into actionable compliance strategies for Roche.
- Showcase analytical and communication skills: Provide examples of how you've dissected complex regulations and communicated technical information to diverse audiences, demonstrating your capability as a Scientist-turned-Regulator and Effective Communicator.
- Demonstrate global collaboration: Detail your experience working in global teams and centers of excellence, showcasing your ability to be a Collaborative Partner within Roche's structure.
- Prepare for STAR method interviews: Be ready to discuss specific projects where you led regulatory assessments, impacted analysis, or drove cross-functional implementation, using the Situation, Task, Action, and Result framework.
- Research Roche's values: Align your application and interview responses with Roche's commitment to innovation, healthcare access, and fostering a diverse and inclusive culture.
Technical preparation
Behavioral questions
Frequently asked questions
- What specific environmental regulations will I be working with as a Regulatory Compliance Project Manager at Roche?
- As a Regulatory Compliance Project Manager at Roche, you will primarily focus on interpreting and implementing environmental product regulations such as Biocides, RoHS, and F-Gas, among others, to ensure global product compliance.
- What is the primary location for this Regulatory Compliance Project Manager role at Roche?
- The primary location for this Regulatory Compliance Project Manager position at Roche is Sant Cugat del Vallès. Compensation details for other potential locations will be provided later in the hiring process.
- What kind of background is ideal for the Scientist-turned-Regulator profile at Roche?
- The ideal candidate for the Scientist-turned-Regulator profile at Roche possesses a University degree and has practical experience in Product Stewardship or Product Environmental Regulations, with a strong aptitude for analytical thinking and communication.
- How does Roche ensure compliance for its Diagnostics products globally?
- Roche ensures global compliance for its Diagnostics products by having a dedicated Center of Excellence team, led by Project Managers/Regulatory SMEs, who interpret environmental product regulations and drive implementation projects across operational and R&D teams.
- What is expected in terms of collaboration for this Regulatory Compliance Project Manager role at Roche?
- This role requires you to be a Collaborative Partner, thriving in a global Center of Excellence environment and working closely with Monitoring squads and Operational teams to implement regulatory strategies effectively.
- How are regulatory opinions translated into practical compliance actions at Roche?
- Regulatory opinions are translated into practical compliance actions through Product Impact Analyses and Strategic Compliance Roadmaps, which then drive Cross-Functional Implementation projects ensuring operational teams understand and apply these to compliance outputs.
- What makes the Regulatory Compliance Project Manager role impactful at Roche Diagnostics?
- The role is impactful as it ensures Roche Diagnostics products meet global environmental regulations, directly contributing to the company's mission of providing accessible healthcare and its commitment to advancing science.