Fusion - Senior Regulatory Affairs Manager

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success.

We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Who We Are

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day.

We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

In this role, your main purpose and tasks will be the following:

• Obtain Regulatory approvals in defined markets in close cooperation with other functions for the respective area of responsibility.

• Will develop complex regulatory strategies for very complex projects and technologies.

• Oversee Communication plans to various Health Authorities are developed with appropriate stakeholders.

• Maintain the obtained Regulatory approvals/ permits/licenses products throughout the life cycle of the product by applying successful Regulatory change controls.

• Ensure the efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc).

• Ensure the regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.

• Ensure he activities are driven by a mindset of innovation, agility and the principles of VACC leadership.

About the role:

Duties will include, but are not limited to:

• Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of the most complex products/programs.
  
  Develops and manages comprehensive global regulatory submissions and registration plans. Mentors more junior team members in this area.

• External interface management: Leads external complex initiatives including the collaboration with key stakeholders.
  
  Cultivates and utilizes external relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Develops/maintains health authority relationships and actively shapes the regulatory environment. Has the ability to represent Roche in audits and other complex stakeholder negotiations.

• Regulatory knowledge and strategy: Lead the organization adapt to evolving regulatory environment and requirements.
  
  Experience in solving complex, critical health authority issues or equivalent 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. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.

• Stakeholder management and influencing: Leads complex initiatives including collaboration with key stakeholders.
  
  Cultivates and utilizes relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Ability to shift the perspectives of key stakeholders to achieve a specified goal.
  
  Builds common ground and alignment even if initial positions were far apart. Negotiates to maximize value for Roche and stakeholders so we have biggest impact for customers and patients.

• Decision making: Has courage to make decisions even outside of scope/comfort zone.
  
  Proactively initiates activities independently and initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level.
  
  Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner.

• Innovation and problem solving: A mindset of creativity and experimentation - a true trailblazer and support radical simplification as well as continuous innovation.
  
  Challenges the organization to be curious, question the status quo and adopt new approaches. Fosters a culture that leverages diversity and unique perspectives. Has vision; often brings up ideas about potentials and possibilities for the future.
  
  Actively drives new ideas/ approaches into the business. Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur and actively drives mitigation strategies to avoid them. Leads others in problem-solving activities.

• VAAC Leadership and agility: Role model for we all lead.
  
  Actively develops VACC competencies and deploys them in our daily work. Fosters an inclusive environment which supports all dimensions of diversity. Shows dedication to advancement of others.
  
  Demonstrates commitment to identify, solicit and provide growth opportunities for others.
  
  Demonstrates outstanding achievement in areas of technical expertise, leading innovation and/or mobilizing the organization. Change ambassador for their environment and actively develops their agile mindsets and behaviors and encourages others to do so as well. Identifies and acts on opportunities for improvement within and across Q&R - embraces new technologies and other means to simplify and increase productivity

• Teamwork and communication: Is able to pull people together around a common goal.
  
  Seeks to understand and build on different perspectives to enhance outcomes. Addresses and resolves conflict by creating an atmosphere of openness and trust. Brings out the best in people and teams.
  
  Establishes an environment for open, honest communication for everyone and ensures that people feel that they are truly heard. Clearly articulates even the most complex concepts. Encourages direct and open discussions about important issues and can be depended on to tell the truth regardless of the circumstances. Courageously speaks the truth regardless hierarchy and creates an environment where people are appreciated and recognized for their contributions.

What you should have in your toolbox:

• Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks and has worked with many years of experience. Advanced degree is considered an advantage.

• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

• 5-10 years experience with PhD degree, 7-10 with Masters degree and 8-10 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.

• Knowledge of the European, US, China and International regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage

• Has demonstrated the ability to manage even the highest complexity of work and/or global projects.

• We are seeking expertise in the diabetes care area particularly with experience in strategic partnering with the FDA (preferred).

Mindset

We@RocheDiagnostics is the mindset and culture we as Diagnostics colleagues strive to adopt to help achieve our vision and realize our strategy. The We@RocheDiagnostics dimensions are:

● We are passionate about our customers and patients

● We radically simplify

● We trust, collaborate & have fun

● We ALL lead

● We experiment & learn

You are expected to demonstrate the We@RocheDiagnostics dimensions and help evolve the function's culture beliefs, bringing them to life as part of the Diagnostics Transformation.

Locations:

You are based in Indianapolis, Tucson, Pleasanton, Santa Clara, Branchburg

Relocation assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Indiana is $115,000 and $213,600. 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.

Benefits

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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.