Fusion - 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.

At 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. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.

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

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

• The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.

• The obtained Regulatory approvals/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls.

• 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).

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

• The activities are driven by a mindset of innovation, agility and the principles of VAAC leadership.

Breakdown of Tasks:

Regulatory document and submission compilation (15%): Oversees the development of submission/product registration dossiers of more complex products/programs. Develops and manages at least parts of comphrehensive global regulatory submissions and registration plans. May act as mentor for more junior team members in this area.

External interface management (15%): Understands the structure, key roles and responsibilities of external customers/stakeholders. Understands and communicates timely and effectively the needs of external customers/stakeholders.

Builds effective and enduring external relationships and applies effective stakeholder management practices. Actively contributes to audits by supporting preparation, execution and follow up.

Regulatory knowledge and strategy (10%): Leads the organization to 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 (10%): Effectively partners with stakeholders to understand and provide best solutions. Takes initiative to address problems or opportunities and involves stakeholders for best solutions.

Develops relationships that significantly influence the current and future direction for Roche and our products. Understands what motivates other people to perform at their best. Is skilled at managing and influencing peers.

Fosters an exchange of ideas amongst key stakeholders to be able to shift perspectives to reach a common agreeable outcome. Negotiates with stakeholders and creates win-win compromises.

Decision making (15%): 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 (10%): Drives innovation across the organization/sites. Advocates for and helps progress new ideas that add business value.

Sees the value in others' unique differences. Is entrepreneurial; seizes new opportunities. Works to drive new ideas 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 (10%): Starts to live the spirit of we all lead. Identifies opportunities to develop VACC competency.

Acts with integrity, courage, passion and honors commitments. Contributes an inclusive environment which supports all dimensions of diversity. Explores the opportunity of leadership and future contribution.

Takes initiative when opportunities arise. Change ambassador for their environment. Actively develops their agile mindsets and behaviors and encourages others to do so as well.

Identifies and acts on opportunities for improvement within across Q&R. Embraces new technologies and other means to simplify and increase productivity.

Teamwork and communication (10%): 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. Makes people feel that they are truly heard.

Expresses complex ideas fluently and clearly. Encourages direct and open discussions about important issues. Can be depended on to tell the truth regardless of the circumstances.

Recognizes and reflects/articulates multiple points of view on an issue. Provides honest input even in difficult situations. Speaks up and actively participate. Creates an environment of recognition and appreciation.

What you should have in your toolbox:

• High degree of subject matter expertise:

• Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks. Advanced degree is considered an advantage.

• 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.

• Technical understanding of medical devices or IVDs

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

• Has demonstrated the ability to manage more complex work and/or at least parts of global projects.

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

Locations:

You are local to 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 Indiana is $100,000 and $185,600. 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.