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Regulatory submissions associate Offres d'emploi - Suisse

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Regulatory submissions associate • suisse

Dernière mise à jour : il y a 17 heures
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Clinical Trial Manager

Clinical Trial Manager

CK GroupSwitzerland
Senior DRA Clinical Trial Manager.We are looking for a Senior Clinical Trial Manager, to join our clients dynamic team in Allschwil. If you're passionate about regulatory affairs and ready to make a...Voir plusDernière mise à jour : il y a 17 heures
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Pharmacometrician

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Regulatory Affairs Manager (m / w / d)

Regulatory Affairs Manager (m / w / d)

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Senior Manager, Regulatory, Digital Health and Device (all genders))

Senior Manager, Regulatory, Digital Health and Device (all genders))

Merck KGaA, Darmstadt, GermanyEysins, Switzerland
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Global Regulatory Affairs Associate, Fast Growing Dermatology Company

Global Regulatory Affairs Associate, Fast Growing Dermatology Company

Stratpharma AGBasel, Basel City, Switzerland
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Clinical Trial Regulatory Lead

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Clinical Operations Lead

Clinical Operations Lead

headcount AGBasel,Switzerland
Quick Apply
Our client, a Swiss biopharmaceutical company, is seeking a.This is a hands-on leadership role, ideal for someone who thrives in dynamic environments and can bring clarity, structure, and motivatio...Voir plusDernière mise à jour : il y a 11 jours
Senior Manager, Regulatory Affairs CMC

Senior Manager, Regulatory Affairs CMC

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The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional ...Voir plusDernière mise à jour : il y a plus de 30 jours
Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

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At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and ot...Voir plusDernière mise à jour : il y a plus de 30 jours
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

IntuitiveAubonne, SWITZERLAND, CH
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Voir plusDernière mise à jour : il y a plus de 30 jours
INTERNATIONAL REGULATORY AFFAIRS 60%

INTERNATIONAL REGULATORY AFFAIRS 60%

gloor & lang Pharma and Biotech RecruitingRegion Zürich-Zug
Innovative Biologic submissions – early to late phase.Our client is an R&D driven biotech company based in in Zurich.Own Research and development activities as well as international clinical develo...Voir plusDernière mise à jour : il y a plus de 30 jours
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Distalmotion SAÉpalinges, VD, CH
Quick Apply
Join Us in Empowering Access to Robotic Surgery.At Distalmotion, we believe patients deserve best-in-class minimally invasive care. Our mission is to empower access to the benefits of robotic surger...Voir plusDernière mise à jour : il y a 17 jours
Managing Environmental Fate and Behaviour Specialist

Managing Environmental Fate and Behaviour Specialist

ExponentBasel, CH
We are currently recruiting for a.Managing Environmental Fate and Behaviour Specialist.Practice in Harrogate (UK), Edinburgh (UK), Mannheim (DE), or Basel (Switzerland) offices.Home working may als...Voir plusDernière mise à jour : il y a plus de 30 jours
Regulatory Reporting Specialist

Regulatory Reporting Specialist

Crypto Finance AGZürich, ZH, CH
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Quick Apply
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Regulatory Affairs

Regulatory Affairs

Kodiak SciencesSwitzerland
Kodiak Sciences aspires to global leadership in ophthalmology by aggregating top talent, technologies, discoveries, and ideas. We are working to develop disruptive products and platforms to prevent ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Graduate - Regulatory Audit Banking

Graduate - Regulatory Audit Banking

KPMG AGZürich, Stadt Zürich, Schweiz
Werde ab Sommer 2025 Teil unseres erfolgreichen Audit Banking Teams! Im Audit Banking erwartet dich ein dynamisches Umfeld in der finanziellen und regulatorischen Prüfung von grossen und komplexen ...Voir plusDernière mise à jour : il y a plus de 30 jours
Associate Director Regulatory Affairs Small Molecules (f / m / d)

Associate Director Regulatory Affairs Small Molecules (f / m / d)

LonzaBasel, Switzerland
Today, Lonza is a global leader in life sciences operating across three continents.While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented pe...Voir plusDernière mise à jour : il y a plus de 30 jours
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Intuitive SurgicalAubonne, SWITZERLAND, Switzerland
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Voir plusDernière mise à jour : il y a plus de 30 jours
Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Alexion PharmaceuticalsSwitzerland,Baar
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Regulatory Affairs Manager for Austria and Switzerland (Alpine region).Reports to : Associate Director, CENE Regulatory Affairs. The Regulatory Affairs Manager works under the responsibility of the A...Voir plusDernière mise à jour : il y a plus de 30 jours
(Senior) DRA Clinical Trial manager

(Senior) DRA Clinical Trial manager

CTCBasel and NW Switzerland, CH
The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in fi...Voir plusDernière mise à jour : il y a 3 jours
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Clinical Trial Manager

Clinical Trial Manager

CK GroupSwitzerland
Il y a 17 heures
Description de poste

Job Title : Senior DRA Clinical Trial Manager

Location : Allschwil, Switzerland

Work Schedule : Full-time (100%)

Start Date : ASAP

Duration : 12 months (Contract)

We are looking for a Senior Clinical Trial Manager, to join our clients dynamic team in Allschwil. If you're passionate about regulatory affairs and ready to make an impact in the clinical trial space, we want to hear from you.

Key Responsibilities : Clinical Trial Applications (CTAs) :

  • Provide regulatory input and guidance for clinical trials across Europe and internationally.
  • Prepare, submit, and maintain CTAs according to current regulatory requirements.
  • Liaise with internal teams and external service providers (ESPs) to gather and manage submission documents.
  • Communicate with Health Authorities (HAs) and ensure all regulatory deadlines are met throughout the trial lifecycle.
  • Maintain up-to-date tracking sheets and documentation for CTA submissions, amendments, End of Trial notifications, and Clinical Study Report (CSR) synopses.
  • Ensure accurate filing in electronic and paper Trial Master Files (TMFs).

Clinical Trial Team (CTT) Involvement :

  • Actively participate in CTT meetings, offering regulatory insights and guidance.
  • Support CTT members with submission strategy, country timelines, and regulatory processes.
  • Keep stakeholders informed of HA interactions and submission statuses.
  • Additional Responsibilities :

  • Coordinate regulatory aspects of import / export license submissions for applicable countries.
  • Contribute to the development and improvement of SOPs and internal processes.
  • Share expertise, country-specific insights, and support onboarding / training of fellow DRA Clinical Trial Managers.
  • Your Profile :

  • Minimum 2 years' experience as a DRA Clinical Trial Manager (within Viatris or a similar organization).
  • Strong knowledge of clinical trial regulatory requirements, particularly in Europe.
  • Exceptional organizational and communication skills.
  • High attention to detail and the ability to prioritize under tight deadlines.
  • A collaborative, team-oriented mindset with a customer-focused approach.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Fluent in English (written and spoken); knowledge of other European languages is a plus.
  • Why our client

    Our client is more than a pharmaceutical company they are a global team driven by a shared purpose. Join a collaborative environment, where innovation is encouraged, and your expertise will contribute to life-changing therapies worldwide.

    Apply :

    It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.