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Tucson, Arizona, United States · On-site
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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 …
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Indianapolis, Indiana, United States · On-site
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Oversee the compilation of regulatory documents and submission dossiers for complex companion diagnostic products. Develop global registration plans and manage relationships with external stakeholders and regulators to accelerate worldwide approvals.
Requires a degree in Life Science or Data Science with 3-8 years of experience in Regulatory Affairs depending on the level of education. Knowledge of US, European, and Chinese regulations for IVDs and medical devices is highly advantageous.
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.
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in Companion Diagnostics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.
The Opportunity
You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans.
You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.
You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
You effectively partner with external and internal stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.
You have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.
You model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment.
You are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams.
Who you are
You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs
You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
You have demonstrated the ability to manage more complex work and/or at parts of global projects.
Locations
You are local to Indianapolis or Penzberg
No relocation benefits are available for this position.
The expected salary range for this position based on the primary location of Indiana is $106,100 and $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
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