Regulatory Affairs Manager, Companion Diagnostics

Roche • Indianapolis, IN

2d • Onsite

About The Position

At Roche, we foster a culture where you can be yourself and are embraced for your unique qualities. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected, allowing you to thrive 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 is what drives us to innovate and continuously advance science, ensuring everyone has access to the healthcare they need. Creating a world where we all have more time with the people we love is 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 a 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 countries.

Requirements

• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
• 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.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Oversee regulatory document and submission compilation, including the development of submission/product registration dossiers of more complex products/programs.
• Develop and manage parts of comprehensive global regulatory submissions and registration plans.
• Interface with external management.
• Understand the structure, key roles, and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
• Build effective and enduring external relationships and apply effective stakeholder management practices.
• Contribute to audits by supporting preparation, execution, and follow-up.
• Lead the organization to adapt to the evolving regulatory environment and requirements.
• Have an understanding of external environmental changes and precedents to navigate complex situations and influence strategies and decision-making.
• Interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance.
• Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
• Effectively partner with external and internal stakeholders to understand and provide best solutions.
• Take initiative to address problems or opportunities and involve collaborators for best solutions.
• Develop relationships that significantly influence the current and future direction for Roche and our products.
• Make decisions even outside of scope/comfort zone and proactively initiate activities independently.
• Embrace good decision-making principles.
• Model VAAC Leadership and agility.
• Identify opportunities to develop VACC competency.
• Act with integrity, courage, passion, and honor commitments and contribute to an inclusive environment.
• Pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes.
• Address and resolve conflict by creating an atmosphere of openness and trust.
• Bring out the best in people and teams.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager