Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Professional - Basel, Basel-Stadt - Lonza

  • Regulatory Affairs Manager für Arzneimittelprojekte in der Schweiz

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    Über unsGloor & Lang AG ist ein Beratungs- und Dienstleistungsunternehmen im Raum Basel, das sich auf die Unterstützung nationaler und internationaler Pharma- und Gesundheitsunternehmen bei regulatorischen und qualitätstechnischen Fragen spezialisiert hat. Unsere erfahrenen Experten bieten eine breite Palette von Services an, um unsere Kunden zu...

  • Regulatory Affairs Expert für Zulassung von Arzneimitteln in der Schweiz

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    Jobbeschreibung:Sie suchen eine Herausforderung als Regulatory Affairs Expert in einer kleinen, dynamischen Firma im Raum Basel? Wir bieten Ihnen die Möglichkeit, Ihre Kenntnisse und Erfahrungen in der Zulassung von Arzneimitteln in der Schweiz einzubringen und unsere Kunden zu unterstützen.UnternehmensübersichtUnser Unternehmen, gloor&lang AG, ist ein...

  • Regulatory Affairs Manager Schweiz: Professionelle Herausforderung für Fachexperten

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    **Überblick:** Unsere Kunden aus dem Pharma- und Gesundheitsbereich suchen nach Experten, die helfen können, regulatorische und qualitätstechnische Fragen zu lösen. Wir suchen deshalb einen erfahrenen Regulatory Affairs Manager, der neue Projekte in der Schweiz betreut.**Gehalt:** 120'000 - 150'000 CHF pro Jahr (abhängig von Erfahrung und...

  • Global Governance Expert

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job DescriptionLocation: Basel, SwitzerlandAbout the RoleWe are seeking a seasoned professional to join our team as a Senior Manager, Public Affairs Governance. As a key member of our Public Affairs department, you will be responsible for ensuring robust governance oversight and compliance within Public Affairs activities globally.Your primary focus will be...

  • Strategic Public Affairs Leader

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Novartis is a leading pharmaceutical company with a strong commitment to excellence and innovation. We are seeking an experienced Strategic Public Affairs Leader to spearhead our efforts in the SERCE cluster.Job SummaryThis is a full-time position based in Basel, Switzerland. The successful candidate will have extensive experience in public affairs and/or...

  • Strategic Governance Expert

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job Description SummaryLocation: Basel, SwitzerlandThe Strategic Governance Expert - Public Affairs will be responsible for ensuring robust governance oversight and compliance within Public Affairs activities globally. This role will focus on identifying potential risks related to corporate governance and lobbying, providing guidance to internal...

  • Senior Manager, Public Affairs Governance Director

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job DescriptionThe Senior Manager, Public Affairs Governance Director will be responsible for ensuring robust governance oversight and compliance within Public Affairs activities globally. This role requires strong analytical skills, scenario planning capabilities, and the ability to translate complex data into actionable strategies for senior...

  • Public Affairs Strategist

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    At Novartis, we're driven by our mission to reimagine medicine and bring new hope to patients. We're seeking a highly skilled Public Affairs Strategist to lead our efforts in the European Cluster.About the RoleThis is an exceptional opportunity for a seasoned professional with a strong background in public affairs and policy strategy to join our team as a...

  • Strategic Public Affairs Lead for EU Cluster

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job Title: Strategic Public Affairs Lead for EU ClusterAbout Us: As a leading healthcare company, Novartis is committed to improving people's lives through innovative medicines and treatments. We are seeking an experienced Public Affairs Specialist to join our team in Basel, Switzerland.Job Description: The successful candidate will lead policy thought...

  • Statistician - Pharmaceutical Industry Specialist

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA is a leading staffing company in Switzerland, connecting candidates with companies and creating value in the labour market. We are currently seeking an experienced Statistician to join our team in Basel.The ideal candidate will have a strong background in statistics, biostatistics, or a related field, and advanced proficiency in statistical...

  • Data Scientist

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Company Overview: Gi Group SA is a globally leading pharmaceutical company in Basel, Switzerland. With a focus on synthetic molecule development and commercial manufacturing, the company requires experienced data scientists to support their operations.Job Description:Data Analysis: The successful candidate will be responsible for analyzing GMP data, process...

  • Product Safety Specialist

    vor 16 Stunden

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Job DescriptionWe are seeking a highly qualified Product Safety Specialist to join our team in Basel. As a member of our global unit "Diagnostics Product Sustainability & Compliance", you will be responsible for ensuring compliance with chemical and environmental regulations.The ideal candidate will have completed studies in environmental sciences, natural...

  • Global Health Policy Expert for Novartis

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Company OverviewNovartis is a leading global healthcare company that reimagines medicine to improve and extend people's lives.We are committed to becoming the most valued and trusted medicines company in the world by delivering innovative treatments, exceptional service, and sustainable growth.Job DescriptionAs a Global Health Policy Expert for Novartis, you...

  • Medizinische Angelegenheiten-Strategin

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA ist ein führender Anbieter von medizinischen Geräten und pharmazeutischen Produkten in der Zentralschweiz. Wir suchen eine engagierte Persönlichkeit für die Position des Medical Scientific Affairs Managers (w/m/d). Zu den Hauptaufgaben gehören: - Fachlicher Support bei der Entwicklung medizinisch wissenschaftlicher Aussagen in den Bereichen...

  • Wissenschaftlicher Projektmanager für medizinische Angelegenheiten

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA bietet eine spannende Herausforderung in der Pharma-Industrie an. Als Medical Scientific Affairs Manager unterstützen Sie den Kunden bei der Gestaltung seiner medizinischen Präsenz und tragen zum Erfolg von klinischen Studien bei.AufgabenFachlicher Support zu medizinisch-wissenschaftlichen Produktaussagen in den Bereichen Haut- und...

  • Medizinischer Fachexperte für Produktentwicklung

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Unser Kunde, ein führender Hersteller von medizinischen Geräten und pharmazeutischen Produkten in der Zentralschweiz, sucht einen engagierten Medizinischen Fachexperten als Medical Scientific Affairs Manager.AufgabenFachlicher Support zu medizinisch wissenschaftlichen Produktaussagen im Bereich Haut- und Wundmanagement.Planung und Durchführung von...

  • Wissenschaftlicher Fachmann für medizinische Produkte

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Beschreibung der PositionAls Medical Scientific Affairs Manager sind Sie der wissenschaftliche Experte unseres Kunden, eines führenden Anbieters von medizinischen Geräten und pharmazeutischen Produkten in der Zentralschweiz. Ihre Aufgaben umfassen:Fachlicher Support zu medizinisch-wissenschaftlichen Produktaussagen in den Bereichen Haut- und...

  • Wissenschaftlicher Projektleiter Medizinische Angelegenheiten

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    BerufsschwerpunkteIn der Position als Medical Scientific Affairs Manager sind Sie für den medizinischen Bereich verantwortlich. Hierbei unterstützen Sie die Entwicklung von medizinischen Geräten und pharmazeutischen Produkten.AufgabenFachlicher Support zu medizinisch wissenschaftlichen Produktaussagen in den Bereichen Haut- und Wundmanagement.Planung und...

  • Statistician - Pharmaceutical Industry Expert

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA is a globally leading pharmaceutical company seeking experienced statisticians with first touchpoints in the industry.We are looking for professionals who can collaborate on synthetic molecule development and commercial manufacturing. The ideal candidate will have expertise in statistical methods, design of experiments, and data analysis.The role...

  • Global Health Policy Strategist

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job Summary:We're seeking a seasoned professional to join our team as a Global Health Policy Strategist. As part of our policy shaping efforts, you will focus on collaborating with multilateral organizations to identify and address global health risks and opportunities.About the Role:Main Responsibilities:Monitor and analyze multilateral organizations to...

Regulatory Affairs Professional

vor 1 Monat

Basel, Basel-Stadt, Schweiz Lonza Vollzeit
Job Description

We are seeking a highly skilled Regulatory Affairs Professional to join our team at Lonza. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our biologics products with global regulatory requirements.

Key Responsibilities:
  • Author and review Module 3.2 dossier sections for customer filings, including IND/IMPD, BLA/MAA, and life cycle variations submissions.
  • Lead and coordinate submission-related activities to ensure timely delivery of regulatory documents in accordance with Lonza procedures and good practices.
  • Act as the primary point of contact for assigned projects and provide regulatory support to internal project teams.
  • Track and negotiate source document availability required for clinical and commercial submissions.
  • Prepare and review responses to health authority submission review questions (RtQs) and briefing documents for scientific advice meetings.
  • Attend customer meetings and provide regulatory advice for assigned projects.
Requirements:
  • A Master's degree in Biology, Chemistry, Biochemistry, Pharmacy, or equivalent, with a preference for higher education (PhD, PharmD) or Regulatory Affairs Certification (RAC).
  • At least 5 years of experience in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices through the product life-cycle.
  • Ability to work autonomously and in a team environment.
  • Previous experience in a CMO/CDMO environment is a significant advantage.
  • Exceptional communication and interpersonal skills, with the ability to interact with internal and external customers regularly in a global environment across time zones.
  • Experience in leading project teams to successful filings and approvals.
  • Demonstrated skills in managing project timelines and priorities.
Benefits:
  • A competitive salary of $120,000-$150,000 per year, depending on experience.
  • Hybrid work conditions that offer a balance between remote work and collaboration in the office.
  • The opportunity to work on complex projects that have a positive impact on millions of people worldwide.
  • A collaborative and dynamic work environment that values creativity and innovation.