At a Glance
- Tasks: Drive global regulatory disclosures and ensure compliance with evolving requirements.
- Company: Join Roche, a leader in medical advancements and ethical commitments.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and transparency.
- Why this job: Make a real impact on patient access to vital clinical information.
- Qualifications: Experience in regulatory affairs and strong project management skills required.
The predicted salary is between 60000 - 80000 € per year.
Are you passionate about transparency and ensuring critical clinical trial data reaches the public? Join the Product Development Regulatory Affairs (PDR) Data and Content Chapter, where you will drive the strategy and execution of global regulatory disclosures. This is an opportunity to play a pivotal role in upholding Roche’s ethical commitments and shaping how patients, healthcare professionals, and the scientific community access vital clinical information.
You will ensure compliance with evolving global disclosure requirements while protecting sensitive information, contributing directly to Roche’s mission to deliver meaningful medical advances for patients worldwide.
- Ensure strategic compliance: Provide expert regulatory guidance to ensure Roche meets global disclosure requirements while safeguarding Personal Protected Data and Company Confidential Information.
- Lead global trial registration: Drive the accurate and timely posting of clinical trial protocols and study results to public registries such as ClinicalTrials.gov and the EU results registry.
- Enhance process excellence: Lead cross-functional initiatives to optimize information and process flow, translating business needs into efficient, globally aligned system enhancements.
- Mentor and influence: Act as a Global or Business Process Owner and Subject Matter Expert, mentoring colleagues and helping to shape the internal and external environment for regulatory transparency.
- Collaborate across functions: Partner with project teams, affiliates, and other cross-functional stakeholders to secure data, coordinate reviews, and ensure high-quality and consistent disclosure deliverables.
- Shape regulatory transparency: Contribute to internal and external efforts to advance Roche’s leadership in regulatory transparency, maintaining awareness of emerging global requirements and trends.
Qualifications
- Strong and proven experience, including several years supporting cross-functional teams in a scientific or regulatory environment.
- Degree in Life Sciences or equivalent.
- Demonstrated project management expertise, with exceptional attention to detail and the ability to deliver high-quality work under challenging timelines.
- Proven ability to influence and collaborate effectively across global, cross-functional teams.
- Excellent written and verbal communication skills, with fluency in English.
- Extensive experience in regulatory affairs or other product development functions, and a deep understanding of global regulations, disclosure processes, and drug/biologics development (including GxP and GCP) is preferred.
All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care.
Regulatory Transparency (Disclosures) Manager employer: Roche
Roche is an exceptional employer that champions transparency and ethical commitments in the healthcare sector. With a strong focus on employee growth, we offer opportunities for mentorship and collaboration across global teams, fostering a culture of innovation and excellence. Located in a dynamic environment, Roche provides flexible working arrangements and a commitment to meaningful medical advancements, making it an ideal place for professionals passionate about regulatory affairs and patient impact.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Transparency (Disclosures) Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Understand Roche's commitment to transparency and how your skills align with their mission. We want you to shine and show them why you're the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. We believe that being well-prepared will boost your confidence and help you tackle those tricky questions.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your enthusiasm for the role. We recommend applying through our website to keep everything streamlined and easy for you.
We think you need these skills to ace Regulatory Transparency (Disclosures) Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Regulatory Transparency Manager role. Highlight your experience in regulatory affairs and project management, as these are key to what we’re looking for.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to express your passion for transparency and how you can contribute to Roche’s mission. Be specific about your relevant experiences and how they relate to the job description.
Showcase Your Communication Skills:Since excellent written communication is crucial for this role, ensure your application is clear, concise, and free of errors. We want to see your ability to convey complex information effectively!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Roche
✨Know Your Regulatory Stuff
Make sure you brush up on global disclosure requirements and regulations relevant to clinical trials. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you truly understand the complexities involved.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed projects in the past, especially in cross-functional teams. Highlight your attention to detail and ability to deliver under pressure, as these are crucial for the role.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Since excellent communication skills are a must, consider doing mock interviews with friends or using online platforms to refine your verbal skills.
✨Demonstrate Your Collaborative Spirit
Think of instances where you've worked effectively with diverse teams. Be ready to discuss how you’ve influenced others and contributed to a positive team environment, as collaboration is key in this role.