Regulatory Affairs Manager

About the role

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.

Responsibilities

• Oversight of regulatory document and submission compilation, including the development of submission/product registration dossiers of more complex products/programs.
• Development and management of parts of comprehensive global regulatory submissions and registration plans.
• Knowledge of USFDA regulations including Research Use Only (RUO) and IVD marketing pathways.
• Interface with external management, understanding the structure, key roles, and responsibilities of external customers/stakeholders and communicating their needs.
• 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.
• Understand and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance.
• Create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
• Partner with end influence 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.
• Made decisions even outside of scope/comfort zone and proactively initiate activities independently.
• 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 which supports all dimensions of diversity.
• 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.

Requirements

• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
• Advanced degree preferred.
• 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.
• 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.

Qualifications

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

Skills

• Understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making.
• 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.
• Proactive creation of unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.
• Effectively partnering with end influence stakeholders to understand and provide best solutions.
• Initiative to address problems or opportunities and involve collaborators for best solutions.
• Development of relationships that significantly influence the current and future direction for Roche and our products.
• Ability to make decisions even outside of scope/comfort zone and proactively initiate activities independently.
• Modeling VAAC Leadership and agility.
• Identification of opportunities to develop VACC competency.
• Acting with integrity, courage, passion, and honor commitments and contributing to an inclusive environment which supports all dimensions of diversity.
• Pulling people together around a common goal and seeking to understand and build on different perspectives to enhance outcomes.
• Addressing and resolving conflict by creating an atmosphere of openness and trust.
• Bringing out the best in people and teams.

Benefits

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 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.