Regulatory Affairs Manager

Location: Indianapolis

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

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 systems and software including hardware-software instrument systems. This role will specifically support our Sequencing portfolio in our Molecular Customer Area. 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. Specifically, you bring knowledge of USFDA regulations including Research Use Only (RUO) and IVD marketing pathways.
• 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 world wide approvals.
• You effectively partner with end influence 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 which supports all dimensions of diversity.
• 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 or equivalent.
• 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.

Preferred

• You have experience with complex regulatory product launch strategies including advertisement and promotional reviews for Research Use Only (RUO) and IVD products pertaining to Sequencing technologies.

Locations

You are local to Indianapolis, Branchburg, Tucson, Santa Clara, Pleasanton, or Carlsbad.

* Relocation assistance is not available for this position.
* The expected salary range for this position based on the primary location of Indianapolis is $106,000-$197,000. Actual pay will be determined based on…