Suzhou, Jiangsu, China · On-site
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 …
Skills: Regulatory Affairs, Submission Compilation, Stakeholder Management, Regulatory Strategy, IVD Regulations
Xuzhou, Jiangsu, China · On-site
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 …
Skills: Medical Knowledge, Pharmaceutical Sales, Medical Affairs, Customer Relationship Management, Clinical Insight Collection
Vienna, Austria · On-site
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 …
Skills: Scientific Writing, Clinical Study Design, Regulatory Documentation, IVDR Compliance, Literature Review
Jinan, Shandong, China · On-site
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 …
Skills: Medical Knowledge, Pharmaceutical Sales, Medical Affairs, Customer Relationship Management, Clinical Insight Collection
Basel, Basel-City, Switzerland · On-site
PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, proces…
Skills: Project Management, Supplier Management, Equipment Qualification, Risk Assessment, C&Q Strategies
Basel, Basel-City, Switzerland · On-site
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 …
Skills: Project Management, Supplier Management, C&Q Strategies, cGMP, ISO 13485
Seoul, South Korea · On-site
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 …
Skills: Laboratory Optimization, Data Analysis, Stakeholder Communication, Workflow Optimization, IVD Industry Knowledge
Vienna, Austria · On-site
$65k/yr
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 …
Skills: Supply Chain Management, Leadership, S&OP Process, KPI Monitoring, Resource Planning
Penzberg, Bavaria, Germany · On-site
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 …
Skills: Oligonucleotide Synthesis, Preparative Organic Synthesis, Purification of Synthesis Products, Nucleic Acid Chemistry, Biochemistry
Kaiseraugst, Aargau, Switzerland · On-site
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 …
Skills: Strategic Planning, Project Management, Stakeholder Management, Business Acumen, Storyboarding
Santa Clara, California, United States · On-site
$72k–$133k/yr
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 …
Skills: Inventory Management, Regulatory Compliance, Material Handling Equipment, Hazardous Materials Handling, SOP Adherence
Mississauga, Ontario, Canada · On-site
$338k–$444k/yr
The Opportunity As the Global Head of Biostatistics, you will provide strategic leadership and oversight across all Therapeutic Area (TA)-aligned Biostatistics teams, ensuring a cohesive and high-performing Biostatistics…
Skills: Strategic Leadership, Biostatistics, Study Design, Data Analysis, Clinical Development
Hillsboro, Oregon, United States · On-site
$114k–$257k/yr
Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Prod…
Skills: Aseptic Processing, Technology Transfer, Process Validation, cGMP Regulations, Data Analysis
Pleasanton, California, United States · On-site
$86k–$160k/yr
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 …
Skills: SHE Policy Development, Regulatory Compliance, Hazard Evaluation, Environmental Auditing, Waste Management
South San Francisco, California, United States · On-site
$96k–$179k/yr
Surgical Device Specialist (SDS), Ophthalmology – NY Metro An ever-transforming healthcare landscape requires a high level of agility and flexibility to navigate. At Genentech, we pride ourselves in our ability to adapt …
Skills: Surgical Device Training, Customer Relationship Management, Consultative Selling, Lead Generation, Technical Education
San José, Costa Rica · On-site
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 …
Skills: Microsoft Active Directory, LDAP, Entra ID, PowerShell Scripting, Infrastructure Design
South San Francisco, California, United States · On-site
$142k–$264k/yr
At Genentech, we are building a scalable and compliant omnichannel engagement ecosystem that enables personalized, data-driven interactions across channels. The Opportunity: As the Omnichannel Email & Paid Media Technica…
Skills: Marketing Technology, Digital Marketing, Marketing Automation, Omnichannel Engagement, Email Marketing
Singapore, Singapore, Singapore · On-site
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 …
Skills: Rockwell PharmaSuite, Emerson DeltaV, IT/OT Integration, cGMP, PI Historian
Bengaluru, Karnataka, India · On-site
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 …
Skills: Retail Sales, Distribution Management, Territory Planning, Pharmacy Relationship Building, HCP Communication
France · On-site
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 …
Skills: Next Generation Sequencing, Molecular Biology, qPCR, NGS Data Analysis, Technical Consulting
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Oversee the development and compilation of regulatory submission dossiers to obtain and maintain product approvals in defined markets. Lead regulatory strategies and manage relationships with external stakeholders and health authorities to accelerate worldwide approvals.
Requires a Bachelor's or Master's degree in Life Science, Data Science, or a related field with 5-10 years of experience in IVD or Medical Device regulatory affairs. Expertise in China, EU, and US regulations is highly preferred.
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.
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 transparent within the organization.
1. Regulatory document and submission compilation:
Oversees the development of submission/product registration dossiers of more complex products/programs. Develops and manages at least parts of comprehensive global regulatory submissions and registration plans. May act as mentor for more junior team members in this area.
2. External interface management:
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.
3. Regulatory knowledge and strategy:
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 worldwide approvals.
4. Stakeholder management and influencing:
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.
5. 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.
6. Innovation and problem solving: :
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.
Requirements
Bachelor’s 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
Preferred: 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
Fluent English
6-8 years with Bachelor degree or 5-7 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs or equivalent
Preferred: 8-10 years with Bachelor degree or 6-8 years with Master’s degree in the field of IVDs/Medical devices with significant experiences in Regulatory Affairs or equivalent
Expertise Knowledge of the China 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
Preferred: Expertise Knowledge of the China, EU and US 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
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH · 4414 Lake Boone Trail, Raleigh, NC 27607, US · 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA · Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE · 333 Buckhead Ave NE, Atlanta, GA 30305, US
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH · 4414 Lake Boone Trail, Raleigh, NC 27607, US · 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA · Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE · 333 Buckhead Ave NE, Atlanta, GA 30305, US
