Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Zürich, Zürich - Takeda
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Regulatory Affairs Manager
vor 1 Monat
Zürich, Zürich, Schweiz bruederlinpartner VollzeitJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at bruederlinpartner. As a Regulatory Affairs Manager, you will be responsible for leading the Regulatory Affairs team and developing global regulatory strategies.Key Responsibilities:Lead the Regulatory Affairs team and develop global regulatory...
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Regulatory Affairs Managerin
Vor 3 Tagen
Zürich, Zürich, Schweiz bruederlinpartner VollzeitRegulatory Affairs ManagerinWir suchen eine erfahrene Regulatory Affairs Managerin, die unser Team bei der Entwicklung und Umsetzung von globalen regulatorischen Strategien unterstützt.Ihre Aufgaben:Leitung des Regulatory Affairs TeamsEntwicklung von Mitarbeiter:innenEntwicklung und Umsetzung von regulatorischen StrategienEinreichung von Zulassungsanträgen...
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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...
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Regulatory Affairs Manager
vor 1 Monat
Zürich, Zürich, Schweiz bruederlinpartner VollzeitPosition as Regulatory Affairs ManagerWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Zürich bei der Umsetzung von regulatorischen Strategien unterstützt.AufgabenLeitung des Regulatory Affairs Teams und Entwicklung von Mitarbeiter:innenEntwicklung und Umsetzung von globalen regulatorischen StrategienVerantwortung...
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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...
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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...
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Regulatory Affairs Specialist
vor 3 Wochen
Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. In this role, you will be responsible for managing end-to-end device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners.Key ResponsibilitiesUtilize regulatory strategy...
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Regulatory Affairs Manager
Vor 6 Tagen
Zürich, Zürich, Schweiz bruederlinpartner VollzeitIhre AufgabenAls Regulatory Affairs Manager (m/w/d) leiten Sie das Regulatory Affairs Team und entwickeln Strategien in diesem Bereich.Unser Unternehmen benötigt Ihre Expertise, um die regulatorischen Anforderungen in der pharmazeutischen Industrie zu erfüllen.Entwicklung und Umsetzung von globalen regulatorischen StrategienLeitung des Regulatory Affairs...
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Regulatory Affairs Specialist
vor 1 Monat
Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryTakeda is seeking a highly skilled Regulatory Affairs Specialist to join our team in Zurich, Switzerland. As a Regulatory Affairs Specialist, you will be responsible for the development and implementation of innovative integral combination product regulatory strategies pertaining to the development, registration, commercialization and life cycle...
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Regulatory Affairs Manager
vor 1 Monat
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...
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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...
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Regulatory Affairs Counsel
vor 2 Monaten
Zürich, Zürich, Schweiz Axiom Vollzeit**About the Role**We are seeking a highly skilled Healthcare/Pharma Legal Expert to join our team at Axiom. As a key member of our legal team, you will work closely with clients across various industries to provide expert legal advice and support.Key Responsibilities:Develop and implement effective legal strategies to support business growth and expansion in...
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Regulatory Compliance Specialist
vor 4 Wochen
Zürich, Zürich, Schweiz SIX VollzeitRegulatory SpecialistAbout the Role:SIX is seeking a highly skilled Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for monitoring regulatory changes in CCP regulations across EU, ES, CH, and UK, and translating them into actionable strategies for SIX Clearing.Key Responsibilities:Stay up-to-date with...
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Regulatory Compliance Expert
Vor 5 Tagen
Zürich, Zürich, Schweiz Axiom VollzeitRegulatory Compliance Expertise:We are seeking a highly skilled Regulatory Compliance Expert to advise our clients on regulatory and compliance matters within the healthcare and pharmaceutical sectors.Key Responsibilities:Develop and implement compliance programs to ensure adherence to pharmacovigilance and medical affairs regulations.Provide legal counsel...
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Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryTakeda is seeking a highly skilled Regulatory Affairs Manager to lead our Device and Drug-Device Combinations Strategic Sourcing Operations. As a key member of our team, you will be responsible for managing end-to-end device and drug-device combination work outsourced by our Global Regulatory Affairs CMC Device and Drug-Device Combinations to...
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Regulatory Affairs Specialist
vor 2 Monaten
Zürich, Zürich, Schweiz Axiom Vollzeit**About the Role**Axiom is seeking a highly skilled Clinical Trials Lawyer to join our team in Switzerland. As a Clinical Trials Lawyer, you will work with various clients across all industries, providing expert advice and counsel on a range of legal matters related to clinical trials, research and development, and related activities.**Key...
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Regulatory Transformation Specialist
Vor 6 Tagen
Zürich, Zürich, Schweiz J Safra Sarasin VollzeitKey ResponsibilitiesWe are seeking a highly skilled Regulatory Transformation Specialist to support our project team in various regulatory financial market related initiatives.Perform gap analyses based on regulatory guidelines to ensure compliance.Derive business requirements to drive project success.Specify solutions leveraging technical and topic experts,...
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Regulatory Transformation Specialist
vor 2 Wochen
Zürich, Zürich, Schweiz J Safra Sarasin VollzeitAbout the RoleWe are seeking a highly skilled Regulatory Transformation Specialist to join our Business & Regulatory Development department at Bank J. Safra Sarasin. As a key member of our project team, you will play a crucial role in supporting our regulatory financial market related initiatives, including the implementation of EMIR Refit requirements and...
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Regulatory Compliance Specialist
Vor 4 Tagen
Zürich, Zürich, Schweiz Alpinum Solutions AG VollzeitWe're seeking an experienced professional to join our team as a Regulatory Compliance Specialist.At Alpinum Solutions AG, we provide managed legal services in Switzerland, Germany, and Liechtenstein. Our latest mandate requires a talented individual to oversee the bank's trading activities, monitor employee and client transactions, and ensure adherence to...
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Regulatory Affairs Manager
Vor 4 Tagen
Zürich, Zürich, Schweiz RMIT Professional Resources AG VollzeitJob Description:As a key member of our team at RMIT Professional Resources AG, you will be responsible for designing and implementing comprehensive EU regulatory strategies to support product approvals and patient access. You will work closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider...
Regulatory Affairs Specialist
vor 2 Monaten
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for clinical trials in the EUCAN and GEM regions.
Key Responsibilities- Develop and implement operational plans for clinical trial applications (CTAs) in EUCAN and GEM regions, ensuring alignment with global submission strategies.
- Execute or oversee all activities related to CTA creation, submission, and maintenance, including coordination with CROs and health authorities.
- Ensure oversight and tracking of CTA activities and eTMF updates, working collaboratively with CROs to ensure compliance.
- Collaborate with Takeda Global and Regional counterparts to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle.
- Present regional CTA regulatory strategies to leadership and senior management, as required.
- Identify regional and national requirements to support submissions of CTAs to Regulatory Authorities.
- Coordinate submission preparations and creation of administrative documents to support initial CTAs and/or maintenance submissions.
- Develop and maintain standardized communication, tracking, and planning tools and templates for internal use.
- Ensure accurate and timely submissions and communication of key regulatory milestones throughout the clinical trial lifecycle.
- Provide regulatory oversight of CRO activities, ensuring compliance with regulatory requirements and guidelines.
- Support non-routine submission activities and deviation follow-up, as needed.
- Provide ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials.
- Participate in proactive solutions to problems arising during the CTA process, in conjunction with senior team members and/or Global/EU Regulatory Lead.
- Bachelor's degree in a scientific field, preferably with advanced degree.
- A minimum of 4 years of experience in drug regulatory affairs, preferably within the EU/GEM region.
- Experience with EU CTR will be advantageous.
- Solid regulatory experience, including knowledge of CTA regulations and guidance governing drugs and biologics in all phases of development.
- Basic regulatory procedure knowledge with major health authorities in the region.
- Excellent analytical and problem-solving skills, with attention to detail and ability to make reasoned recommendations.
- Strong communication and interpersonal skills, with ability to build and maintain relationships.
- Fluency in English.
Takeda is a global top employer that fosters an inclusive, collaborative, and international work environment. We are committed to fostering diversity, equality, and inclusion, and hiring decisions are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.
