Senior Manager/Associate Director, Regulatory, International
vor 4 Wochen
About BridgeBio
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
Who You Are
The international Regulatory Lead role will support the geographical growth for our portfolio. The role will involve strategic planning and hands-on responsibilities to both define the product strategies and implementation of the regulatory strategy for the assigned products and by region. They will also manage regulatory oversight of distributors. Be an active member of the international regulatory team and represent your region’s regulatory voice in defining and shaping the commercial development plans and ensuring operational excellence.
ResponsibilitiesThe Associate Director/Senior Manager will act as the regional lead for the company’s products, supporting regulatory activities and collaborating closely with cross-functional teams to develop and implement regional regulatory strategies. They will work with the Global Regulatory Team in the U.S. to identify and address regulatory risks in the region. As the regional regulatory representative, they will actively participate in reviewing and authoring submission content to support global filings efficiently. The role also involves advising company affiliates on regulatory strategies in the assigned regions for development programs.
- Depending on commercial strategy advise on the best approach to secure regulatory approval in alignment with business objectives
- Support regulatory submissions across new markets, with a focus on Rest of World regions (Americas, Australia, APAC, MENA)
- Build and maintain effective relationships with distributors to streamline market access
The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.
No matter your role at BridgeBio, successful team members are:
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
- Collaborate with internal teams (market access, supply chain) to align regulatory strategy with commercial objectives
- Guide the development of region-specific strategies for orphan products
- Serve as a link between global regulatory teams and BridgeBio affiliates and local distributors to ensure consistent regulatory compliance
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across regulatory authorities for assigned regions
- Participate in the review and approval of essential documents, presentations, and reports
- Occasionally, support EU-based regulatory activities as required
- University Degree in Science or related discipline. A higher degree would be desirable, especially one specific to regulatory affairs
- Extensive knowledge and experience of working in one or more areas in regulatory affairs in the pharmaceutical industry or experience with a health authority for 6-8 years
- Ideally a combined mix of large companies and small biotech
- Experience in regulatory affairs across Rest of World regions, particularly Americas, Australia, APAC or MENA
- Strong interpersonal skills and ability to manage distributor relationships
- Knowledge of regulatory requirements for orphan products is highly desirable
- Ability to work in cross-functional, dynamic teams
- Strong strategic and analytical abilities
- Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs
- Commitment to Diversity, Equity & Inclusion
-
Regulatory Affairs Manager
vor 4 Wochen
Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryTakeda is seeking a highly skilled and experienced Associate Director to lead our Device and Drug-Device Combinations Strategic Sourcing Operations team. As a key member of our Global Regulatory Affairs team, you will be responsible for end-to-end management of device and drug-device combination work outsourced to external partners.Key...
-
Associate Director Business Operations
vor 4 Wochen
Zürich, Zürich, Schweiz Merck Sharp & Dohme (MSD) VollzeitJob DescriptionJob Title: Associate Director, Business OperationLocation: CHN - Beijing - Beijing (Wangjing Park)Job Type: Full timeJob SummaryThe Associate Director of Business Operations will be responsible for leading a team to manage and optimize the operational aspects of R&D China. This role will focus on risk and compliance management, audit,...
-
Associate Director Business Operations
vor 4 Wochen
Zürich, Zürich, Schweiz Merck Sharp & Dohme (MSD) VollzeitJob DescriptionJob Title: Associate Director, Business OperationLocation: CHN - Beijing - Beijing (Wangjing Park)Type: Full timeJob SummaryThe Associate Director of Business Operations will be responsible for leading a team to manage and optimize the operational aspects of R&D China. This role will focus on risk and compliance management, audit,...
-
Zürich, Zürich, Schweiz Barry Callebaut VollzeitAbout the RoleWe are seeking a dynamic leader to drive our global quality and food safety strategy. As Senior Director, Quality Assurance and Regulatory Compliance, you will be responsible for ensuring our products, facilities, processes, and systems meet the required company, customer, and legislative quality standards.Key ResponsibilitiesDevelop and...
-
Regulatory Strategic Sourcing Director
Vor 5 Tagen
Zürich, Zürich, Schweiz Takeda VollzeitAbout the RoleTakeda is seeking a skilled Regulatory Strategic Sourcing Director to lead our device and drug-device combination operations. As a key member of our Global Regulatory Affairs CMC team, you will be responsible for managing end-to-end regulatory strategies for outsourced work.Key ResponsibilitiesDevelop and implement global regulatory best...
-
Senior Audit Associate
vor 4 Wochen
Zürich, Zürich, Schweiz Aequor Consulting GmbH VollzeitAudit Senior Associate / Assistant Manager - Handel & IndustrieWir suchen einen motivierten und analytisch begabten Wirtschaftsprüfer, der sich für die Position als Audit Senior Associate / Assistant Manager - Handel & Industrie begeistern kann.AufgabenbereichPrüfung von Jahres- und Konzernrechnungen und Bewertung der Einhaltung aufsichtsrechtlicher...
-
Tax Manager in International M&A
vor 4 Wochen
Zürich, Schweiz Kingpin International VollzeitSeize this opportunity to be part of a pioneering team in Zurich, where innovation meets excellence, as the brand-new Tax Manager specialising in International M&A. If you're passionate about driving transformative change and thrive in a fast-paced environment, we want you on board! What we can offer you Recognising the importance of career transitions, we...
-
Regulatory Affairs Specialist
vor 2 Monaten
Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking an experienced Associate Director to lead our Device and Drug-Device Combinations EU and Global Markets team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing innovative regulatory strategies for our combination product portfolio.Key ResponsibilitiesDevelop and implement...
-
Senior Director of Data Transformation
vor 2 Wochen
Zürich, Zürich, Schweiz Mondelēz International VollzeitData Transformation OpportunityAbout Mondelēz InternationalMondelēz International is a leading global snacking company committed to empowering people to snack right. We're looking for a highly skilled Senior Director of Data Transformation to lead our data management transformation efforts.Job SummaryThe Senior Director of Data Transformation will be...
-
Senior Regulatory Science Manager
vor 4 Wochen
Zürich, Schweiz Givaudan VollzeitStep into our world of creativity and joy! Senior Regulatory Science Manager Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to learn and many...
-
Senior SAP Manager/Director
vor 3 Wochen
Zürich, Zürich, Schweiz EPAM Systems VollzeitJob Title: Senior SAP Manager/DirectorAbout the Role:As a Senior SAP Manager/Director at EPAM Systems, you will play a pivotal role in shaping and guiding our customer engagements across the retail and consumer goods sector on a European scale. This position requires a proactive, self-motivated, and highly organized individual who can dictate key decisions,...
-
Senior SAP Manager/Director
vor 3 Wochen
Zürich, Zürich, Schweiz EPAM Systems VollzeitJob Title: Senior SAP Manager/DirectorAbout the Role:As the Senior Manager/Director of SAP Consumer Goods and Retail Solutions, you will shape and guide our customer engagements across our extensive retail and consumer portfolio on a European scale. This role requires a proactive, self-motivated and highly organized individual. You will dictate key...
-
Senior SAP Manager/Director
vor 4 Wochen
Zürich, Zürich, Schweiz EPAM Systems VollzeitJob Title: Senior SAP Manager/DirectorAs a Senior SAP Manager/Director at EPAM Systems, you will play a key role in shaping and guiding our customer engagements across our extensive retail and consumer portfolio on a European scale.Key Responsibilities:Lead and manage SAP teams across multiple countries, ensuring performance in the SAP CPG sector.Deliver...
-
Senior SAP Manager/Director
vor 4 Wochen
Zürich, Zürich, Schweiz EPAM Systems VollzeitJob Title: Senior SAP Manager/DirectorAs a Senior Manager/Director of SAP Consumer Goods and Retail Solutions, you will play a pivotal role in shaping and guiding our customer engagements across our extensive retail and consumer portfolio on a European scale.Key Responsibilities:Lead and manage SAP teams across multiple countries, ensuring performance in the...
-
Senior Regulatory Science Manager
vor 4 Wochen
Zürich, Schweiz Givaudan VollzeitGivaudan is the global leader in the creation of flavours and fragrances. In close collaboration with food, beverage, consumer product and fragrance partners, Givaudan develops tastes and scents that delight consumers the world over. With a passion to understand consumers’ preferences and a relentless drive to innovate, Givaudan is at the forefront of...
-
Regulatory Affairs Manager
vor 3 Wochen
Zürich, Zürich, Schweiz bruederlinpartner VollzeitRegulatory Affairs ManagerWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Zürich unterstützen kann.AufgabenLeitung des Regulatory Affairs Teams und Entwicklung von Mitarbeiter:innenEntwicklung und Umsetzung von globalen regulatorischen StrategienVerantwortung für die Einreichung von Zulassungsanträgen bei...
-
Regulatory Affairs Manager
vor 2 Wochen
Zürich, Zürich, Schweiz bruederlinpartner VollzeitSie suchen nach einer Herausforderung, die Ihre Fähigkeiten als Regulatory Affairs Manager auslotet?Wir suchen bei bruederlinpartner einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Zürich unterstützt.Ihre Aufgaben:Leitung des Regulatory Affairs TeamsEntwicklung und Umsetzung von globalen regulatorischen StrategienVerantwortung...
-
Head Regulatory Manager
Vor 7 Tagen
Zürich, Zürich, Schweiz SIX VollzeitKey ResponsibilitiesAs Head RegulatoryDevelop and implement a coordinated regulatory approach across the SIX Group to ensure effective compliance with key regulations.Provide expert regulatory advice to non-business units.Manage key communications with regulators and national banks, preparing and accompanying regulatory meetings to ensure consistent...
-
Senior Trust and Fiduciary Services Director
vor 2 Wochen
Zürich, Zürich, Schweiz Page Executive Vollzeit**Senior Trust and Fiduciary Services Director Opportunity**We are seeking an exceptional Trust and Fiduciary Services Director to lead our team in delivering high-quality services to our clients. As a key member of our leadership team, you will be responsible for driving business growth, developing and implementing strategies, and ensuring compliance with...
-
Senior Director of Omnichannel Technology Strategy
vor 2 Wochen
Zürich, Zürich, Schweiz Mondelēz International VollzeitAbout the Role:Mondelēz International is seeking a highly experienced Senior Director of Omnichannel Technology Strategy to lead the development and implementation of our company's omnichannel strategy.This role will be responsible for providing technical leadership and vision for the development and delivery of omnichannel solutions that drive business...
