Global Program Regulatory Director

vor 4 Wochen

Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit
Job ID REQ May 07, 2024 Switzerland SummaryThe Global Program Regulatory Director (GPRD) Medical Device & IVD Excellence EU & ROW provides global regulatory leadership throughout the lifecycle of a development and/or marketed product program(s). Using prior education and experience, the GPRD Medical Device & IVD Excellence EU & ROW integrates multiple inputs to create a coherent global regulatory strategy for MDs and IVDs fulfilling objectives. Responsible for identifying regulatory opportunities and executing the strategy across regions. Leads high functioning global regulatory subteam(s) and provides expertise for program strategy. Represents RA Medical Devices & Precision Medicine on program subteams and cross-functional committees. About the Role

Major accountabilities:

  • In collaboration, develop high quality global regulatory strategies related to Medical Devices & IVDs.
  • Evaluate and communicate potential regulatory risks and develop mitigation strategies for the program.
  • Leverage regional expertise for global regulatory strategies and Health Authorities engagement, focusing on EU and ROW.
  • Provide strategic regulatory input on key documents and lead execution of the regulatory strategy including submission planning and critical review.
  • Lead interactions with management and external consultants for strategic input on regulatory strategies.
  • Provide input on BD&L Due Diligence evaluations and may serve as local HA liaison.

Key performance indicators:

  • Timely submission of high-quality dossiers
  • Organizational alignment and risk awareness
  • High performing subteams
  • Compliance with external and internal requirements.

Minimum Requirements:
Work Experience:

  • Approximately ≥8 years of regulatory and pharmaceutical development experience
  • Leadership experience in global regulatory and pharmaceutical development activities
  • Strong interpersonal, communication, influencing and problem-solving skills.
  • Adept at navigating organizational complexity.

Skills:

  • Deep knowledge of global regulations for Medical Devices, Drug/Device Combination Products and IVDs.
  • Interpretation and application of regulations and guidance.
  • Regulatory submissions and post-marketing strategies.
  • Understanding of Regulatory operations.

Languages:

  • Fluency in English as a business language. Additional language skills are an asset.

Why Join Us: Collaborating with smart, passionate individuals to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Novartis is committed to fostering an inclusive work environment and diverse teams.

  • Defence Program Director

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Jet Aviation Vollzeit

    Defence Program DirectorLocation:Basel, CHFlexible Work Arrangement: HybridJob Category: Aircraft Maintenance Repair & Overhaul (MRO)Career Level: ManagementRequisition Id: 2584Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft...

  • Defence Program Director

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Jet Aviation Vollzeit

    Defence Program DirectorLocation:Basel, CHFlexible Work Arrangement: HybridJob Category: Aircraft Maintenance Repair & Overhaul (MRO)Career Level: ManagementRequisition Id: 2584Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft...

  • Senior Director, Head of Global Medical Affairs for Pulmonary Hypertension

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz J&J Family of Companies Vollzeit

    Senior Director, Head of Global Medical Affairs for Pulmonary Hypertension WDescriptionJohnson and Johnson Family is recruiting a Senior Director, Head of Global Medical Affairs for Pulmonary Hypertension located in Raritan, NJ or Basil, Switzerland.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to...

  • Director - Ethics, Compliance, and Investigations

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselToday, 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 people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Director - Ethics, Compliance, and Investigations

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselToday, 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 people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Senior Consultant Regulatory Affairs MedTech

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Archons Vollzeit

    Compliance Services - Basel, FrankfurtABOUT ARCONDISArcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients...

  • Senior Consultant Regulatory Affairs MedTech

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Archons Vollzeit

    Compliance Services - Basel, FrankfurtABOUT ARCONDISArcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients...

  • Medical Director Autoimmune Disease

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit

    Job ID REQ May 29, 2024 Switzerland SummaryThe Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area. Develops/ owns Integrated evidence plans(IEP) and provides input into development while ensuring US and Int'l medical perspective is reflected.Is responsible for the...

  • Strategic Program Coordinator

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...

  • Strategic Program Coordinator

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...

  • Associate Director

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit

    Job ID REQ Jun 05, 2024 Switzerland SummaryLocation: Basel, Switzerland Role Purpose: Are you passioned to lead a team of Method Development Experts? Have you successfully developed analytical methods based on QbD Principles? Have you used automation solutions for method development? Do you thrive on challenges and enjoy creating new physicochemical methods...

  • 2024 International Graduate Program

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Straumann Vollzeit

    Are you ready to kick-start your career with a global leader in the medical device industry? Straumann Group is seeking self-aware, digitally-savvy Master's graduates to join our International Graduate Program and help us continue to inspire smiles all over the world As a member of the 2024 cohort, you'll have the opportunity to work on strategic projects,...

  • 2024 International Graduate Program

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Straumann Vollzeit

    Are you ready to kick-start your career with a global leader in the medical device industry? Straumann Group is seeking self-aware, digitally-savvy Master's graduates to join our International Graduate Program and help us continue to inspire smiles all over the world As a member of the 2024 cohort, you'll have the opportunity to work on strategic projects,...

  • Head Clinical Development Pediatric CoE

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit

    Job ID REQ May 20, 2024 Switzerland SummaryWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Head Clinical Development, Pediatric COE. The Head Clinical Development, Pediatric COE is the functional leader of the...

  • Head Clinical Development Pediatric CoE

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit

    Job ID REQ May 20, 2024 Switzerland SummaryWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Head Clinical Development, Pediatric COE. The Head Clinical Development, Pediatric COE is the functional leader of the...

  • Sales Director Aftermarket Services

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Jet Aviation AG Vollzeit

    Sales Director Aftermarket ServicesLocation: Basel, CHFlexible Work Arrangement: Hybrid Job Category: Sales Career Level: Professional Requisition Id: 2446 Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft...

  • Sales Director Aftermarket Services

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Jet Aviation AG Vollzeit

    Sales Director Aftermarket ServicesLocation: Basel, CHFlexible Work Arrangement: Hybrid Job Category: Sales Career Level: Professional Requisition Id: 2446 Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft...

  • Regulatory Affairs Manager 100%

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Medartis AG Vollzeit

    Wir bieten eine spannende Stelle an unserem Hauptsitz in Basel als Regulatory Affairs Manager 100%Ihr AufgabengebietSicherstellung der Einhaltung von regulatorischen Anforderungen für die Entwicklung, Herstellung und Markteinführung von Medizinprodukten Erstellung und Zusammenstellung der für die Zulassung nötigen Unterlagen (weltweit) Ansprechpartner...

  • Regulatory Affairs Manager 100%

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Medartis AG Vollzeit

    Wir bieten eine spannende Stelle an unserem Hauptsitz in Basel als Regulatory Affairs Manager 100%Ihr AufgabengebietSicherstellung der Einhaltung von regulatorischen Anforderungen für die Entwicklung, Herstellung und Markteinführung von Medizinprodukten Erstellung und Zusammenstellung der für die Zulassung nötigen Unterlagen (weltweit) Ansprechpartner...

  • Director, Delivery

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz J&J Family of Companies Vollzeit

    Director, Delivery - Innovative Health WDescriptionJohnson & Johnson is recruiting for a Director, Delivery - Innovative Health located in Spring House, PA; Raritan, NJ; Titusville, NJ; High Wycombe, United Kingdom; Basel, Switzerland or Beerse, Belgium.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us...