Aktuelle Jobs im Zusammenhang mit CMC Regulatory Strategy Lead - Innsbruck, Tirol - Novartis Farmacéutica
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Regulatory Affairs Associate
vor 2 Wochen
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Medical Device Development Lead
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Senior Analytical Lead
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Senior Product Manager
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Clinical Education Training Lead
vor 2 Monaten
Innsbruck, Tirol, Österreich MED-EL Medical Electronics VollzeitAbout MED-ELMED-EL is a premier manufacturer of cutting-edge medical devices designed for the treatment of diverse types and severities of hearing loss. Our distinctive range of implantable hearing solutions positively impacts the lives of countless individuals across more than 140 countries globally. Headquartered in Innsbruck, Austria, MED-EL employs over...
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Head of Sales and Revenue Growth
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Head of Sales
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Senior Medical Device Development Manager
vor 2 Wochen
Innsbruck, Tirol, Österreich X-Therma GmbH VollzeitX-Therma GmbH is a pioneering medical technology company with a strong presence in both San Francisco and Innsbruck, Austria. Our mission is to revolutionize modern medicine through innovative solutions.We are currently seeking a highly skilled Senior Medical Device Development Manager to lead our development projects across various stages – from ideation...
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Project Manager, Customer Portal
vor 3 Wochen
Innsbruck, Tirol, Österreich MED-EL VollzeitJob DescriptionWe are seeking a highly skilled Project Manager, Customer Portal to join our team at MED-EL. As a key member of our product team, you will be responsible for collaborating with stakeholders and cross-functional teams to execute projects aligned with business objectives.Key ResponsibilitiesCollaborate with product owners, stakeholders, and...
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Senior Analytical Scientist
vor 2 Wochen
Innsbruck, Tirol, Österreich Healthcare Businesswomens Association VollzeitJob SummaryWe are seeking a highly skilled Principal Scientist to lead our analytical development team in the development of innovative medicines.About the RoleAs a Principal Scientist, you will be responsible for managing all analytical related activities of drug product development, including release and stability testing, characterization of the API,...
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Global Sales Strategist
Vor 3 Tagen
Innsbruck, Tirol, Österreich Barilla Group VollzeitBarilla WorldwideAs a global food company with Italian roots, we're looking for a talented professional to drive our sales strategy forward. Our company is represented in over 100 countries, with a strong presence in continental Europe, Scandinavia, and Germany. We're seeking a highly motivated individual to join our team as a Global Sales Strategist.Key...
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Enterprise Architect
vor 2 Monaten
Innsbruck, Tirol, Österreich MED-EL Medical Electronics VollzeitAbout MED-EL Medical ElectronicsMED-EL Medical Electronics is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide.Job SummaryWe are seeking an experienced Enterprise...
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Global HR Business Partner
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Digital Marketing Strategist
vor 4 Wochen
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Digital Marketing Strategist
vor 4 Wochen
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Innovation Catalyst
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Key Account Manager
vor 4 Wochen
Innsbruck, Tirol, Österreich Barilla Group VollzeitUnlock Your Potential with Barilla GroupBarilla Group, a leading global food company, is seeking a highly skilled Key Account Manager to join our dynamic team in Innsbruck, Austria. As a key member of our Central & Northern Europe sales department, you will play a crucial role in driving our business growth and success.About the RoleAs a Key Account Manager,...
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Key Account Manager
vor 3 Wochen
Innsbruck, Tirol, Österreich Barilla Group VollzeitBarilla Group is seeking a highly skilled Key Account Manager to join our team in Central & Northern Europe.The ideal candidate will have a strong background in sales and account management, with a proven track record of driving business growth and developing strategic relationships with key customers.Key Responsibilities:Customer Insights: Develop a deep...
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Associate, Regulatory Affairs
vor 5 Monaten
Innsbruck, Österreich MED−EL Elektromedizinische Geräte Gesellschaft m.b.H. VollzeitYour Tasks- Regulatory dossier compilation and submission - Regulatory assessment and submission strategy development - Regulatory itelligence gathering - Management of informational lists and databases - Sales area communications - Your Profile- Written and verbal fluency in English - Attention to detail and excellent organizational skills - Strong...
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Associate, Regulatory Affairs
vor 5 Monaten
Innsbruck, Österreich MED-EL VollzeitRegulatory dossier compilation and submission Regulatory assessment and submission strategy development Regulatory itelligence gathering Management of informational lists and databases Sales area communications Your Profile Written and verbal fluency in English Proficient using PC and MS applications software Attention to detail and...
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Team Lead Marketing
vor 4 Monaten
Innsbruck, Österreich Cropster GmbH VollzeitAbout the role We are looking for a talented and dynamic Marketing Team Lead to join our growing SaaS company in the coffee industry. As the Marketing Team Lead at Cropster, you will be responsible for overseeing the strategic planning, execution, and success of our event marketing, content marketing, product marketing, advertising, brand, and social media...
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Team Lead Marketing
vor 5 Monaten
Innsbruck, Österreich Cropster Vollzeit**About the role**: We are looking for a talented and dynamic **Marketing Team Lead **to join our growing SaaS company in the coffee industry. As the Marketing Team Lead at Cropster, you will be responsible for overseeing the strategic planning, execution, and success of our event marketing, content marketing, product marketing, advertising, brand, and...
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Lead Engineer R&D Medical Devices
vor 2 Wochen
Innsbruck, Österreich X-Therma GmbH VollzeitX-Therma is a fast-moving and innovative startup from San Francisco with an office and hardware R&D branch in Innsbruck, Austria. We are developing breakthrough technology to improve modern medicine and save billions of lives. With our subzero storage and transport solutions, we are enabling global access to organ transplants as well as cell and gene therapy...
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Lead Engineer R&D Medical Devices
vor 2 Wochen
Innsbruck, Österreich X-Therma GmbH VollzeitX-Therma is a fast-moving and innovative startup from San Francisco with an office and hardware R&D branch in Innsbruck, Austria. We are developing breakthrough technology to improve modern medicineand save billions of lives. With our subzero storage and transport solutions, we are enabling global access to organ transplants as well as cell and gene therapy...
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Team Lead Frontend Development
vor 5 Monaten
Innsbruck, Österreich Cropster GmbH VollzeitAbout the role Are you passionate about leading and empowering a talented team of frontend developers? Do you thrive on breaking down barriers and fostering clear communication across departments? If so, we have an exciting opportunity for you! As the Frontend Team Lead, you'll play a crucial role in shaping the direction and efficiency of our frontend...
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Future Leader
vor 5 Monaten
Innsbruck, Österreich Barilla Vollzeit**_Barilla Worldwide_** Barilla is an Italian family-owned food company. Established in 1877, it’s now an international Group present in more than 100 countries. A world leader in the markets of pasta and ready-to-use sauces in continental Europe, bakery products in Italy and crispbread in Scandinavia, the Barilla Group is recognized worldwide as a...
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Team Lead Frontend Development
vor 4 Monaten
Innsbruck, Österreich Cropster Vollzeit**About the role**: Are you passionate about leading and empowering a talented team of frontend developers? Do you thrive on breaking down barriers and fostering clear communication across departments? If so, we have an exciting opportunity for you! As the **Frontend Team Lead**, you'll play a crucial role in shaping the direction and efficiency of our...
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Project Manager, Customer Portal
vor 5 Monaten
Innsbruck, Österreich MED−EL Elektromedizinische Geräte Gesellschaft m.b.H. VollzeitYour Tasks- Collaborate with product owners, stakeholders, and cross-functional software teams to execute projects aligned with business objectives - Facilitate effective communication and coordination within the product team, ensuring clear goals and responsibilities - Track and lead progresses, milestones, and deliverables, providing regular stakeholder...
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Chief Commercial Officer
vor 5 Monaten
Innsbruck, Österreich Cropster GmbH VollzeitAbout the role As the Chief Commercial Officer at Cropster, you will play a pivotal role in driving revenue growth and shaping our commercial strategy as a key member of the Management Team. You will lead a dynamic team of over 30 professionals across Marketing, Sales, Customer Success, Partnerships, Commercial Programs and Analytics. What you'll do -...
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Director of People
vor 5 Monaten
Innsbruck, Österreich BURTON VollzeitAt Burton, we are a purpose-led brand rooted in snowboarding and the outdoors. We fight for the future of our people, planet, and sport. We aim to maximize our positive social impact and minimize our negative environmental impact while delivering high-quality performance products. As a global leader in snowboarding, we’re committed to diversity, equity,...
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Director of People
vor 5 Monaten
Innsbruck, Österreich BURTON VollzeitAt Burton, we are a purpose-led brand rooted in snowboarding and the outdoors. We fight for the future of our people, planet, and sport. We aim to maximize our positive social impact and minimize our negative environmental impact while delivering high-quality performance products. As a global leader in snowboarding, we’re committed to diversity, equity,...
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Pr & Communications Specialist Europe
vor 5 Monaten
Innsbruck, Österreich BURTON EUROPE VollzeitAt Burton, we are a purpose-led brand rooted in snowboarding and the outdoors. We fight for the future of our people, planet, and sport. We aim to maximize our positive social impact and minimize our negative environmental impact while delivering high-quality performance products. As a global leader in snowboarding, we’re committed to diversity, equity,...
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Content Marketing Specialist
vor 5 Monaten
Innsbruck, Österreich Cropster GmbH VollzeitAbout the role As a Content Marketing Specialist, you are a key member of Cropster’s marketing team and work with marketing leadership, customers, and other stakeholders both inside and outside the company. Your goal is to craft compelling and engaging content to build the Cropster brand, building upon the company’s reputation as a leader in specialty...
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Project Manager, Customer Portal
vor 5 Monaten
Innsbruck, Österreich MED-EL VollzeitCollaborate with product owners, stakeholders, and cross-functional software teams to execute projects aligned with business objectives Facilitate effective communication and coordination within the product team, ensuring clear goals and responsibilities Track and lead progresses, milestones, and deliverables, providing regular stakeholder updates and...
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Digital Marketing
vor 4 Wochen
Innsbruck, Österreich CodeQuadrat VollzeitWe are seeking an experienced Digital Marketing Strategist to lead and implement our digital marketing efforts. This role requires a creative and analytical thinker who can develop comprehensive strategies that drive online visibility, engagement, and growth for our brand.TasksDevelop and implement digital marketing strategies aligned with business...
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Digital Marketing
vor 4 Wochen
Innsbruck, Österreich CodeQuadrat VollzeitWe are seeking an experienced Digital Marketing Strategist to lead and implement our digital marketing efforts. This role requires a creative and analytical thinker who can develop comprehensive strategies that drive online visibility, engagement, and growth for our brand. Tasks Develop and implement digital marketing strategies aligned with business...
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Principal Product Manager
vor 1 Woche
Innsbruck, Österreich Dynatrace Austria GmbH VollzeitDynatrace exists to make software work perfectly. Our platform combines broad and deep observability and continuous runtime application security with advanced AIOps to provide answers and intelligent automation from data. This enables innovators to modernize and automate cloud operations, deliver software faster and more securely, and ensure flawless...
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Pr Manager Europe
vor 1 Monat
Innsbruck, Österreich BURTON EUROPE VollzeitAt Burton, we are a purpose-led brand rooted in snowboarding and the outdoors. We fight for the future of our people, planet, and sport. We aim to maximize our positive social impact and minimize our negative environmental impact while delivering high-quality performance products. As a global leader in snowboarding, we’re committed to diversity, equity,...
CMC Regulatory Strategy Lead
vor 2 Monaten
Key Responsibilities:
- Develop and execute global CMC regulatory strategies for Biologics or Small Molecules projects/products, leveraging substantial regulatory expertise to drive innovation and maximize business benefits while ensuring regulatory compliance.
- Lead global CMC submission activities, including planning, authoring, reviewing, coordination, and submission, ensuring seamless execution and alignment with global strategies.
- Identify and address documentation and content quality issues for global submissions, negotiating delivery of approved technical source documents within project timelines.
- Author and/or review high-quality CMC documentation for Health Authority submissions, applying global regulatory strategies, current trends, and guidelines to ensure technical congruency and regulatory compliance.
- Represent Global Regulatory CMC on cross-functional project teams, fostering collaborative partnerships with stakeholders.
- Initiate and lead Health Authority interactions and negotiations, setting objectives, preparing briefing books, and coordinating rehearsals and risk mitigation plans.
- Provide strategic advice and direction within the department and cross-functionally through specialized assignments.
Education: A science degree (e.g., Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; an advanced degree is desired.
Experience: A minimum of 8 years of regulatory experience, preferably in the pharmaceutical industry, with substantial knowledge/experience in regulatory submission and approval processes and the ability to deal with complex CMC regulatory issues and requirements.
Commitment to Diversity & InclusionNovartis Farmacéutica is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
