Director, Global Regulatory Affairs

vor 1 Woche


Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

VectivBio in Collaboration with Ironwood Pharmaceuticals: Join the Team

Purpose of this Position:

The GRA Director will provide regulatory guidance and strategies for product development, ensuring market approvals align with business goals and regulations. This role involves anticipating and overcoming regulatory challenges to drive successful projects.

Location: Basel, Switzerland (with remote work) and occasional travel to Boston, USA.

Key Responsibilities:

  • Develop and implement global regulatory strategies for projects
  • Lead submission team meetings and ensure adherence to schedules
  • Coordinate partner submissions and address issues effectively
  • Prepare regulatory documents and applications
  • Stay updated on US and EU regulations
  • Proactively identify and address risks
  • Interpret scientific data for regulatory strategies
  • Represent the company at regulatory agencies
  • Share Regulatory Intelligence and ensure timelines are met
  • Report progress to management regularly
  • Other regulatory duties as needed

Profile Requirements:

  • Bachelor's degree in a science field (Advanced degree preferred)
  • 8+ years of Regulatory Affairs experience
  • Strong strategic development capabilities
  • Global Regulatory Affairs track record
  • Excellent communication and interpersonal skills
  • Team player with leadership abilities
  • Good time management and project management skills
  • Proficient in computer skills


  • Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Global Regulatory Affairs DirectorWe are looking for a person who will develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans.Responsibilities Participate in or lead departmental...


  • Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description:The Director Regulatory Affairs will be responsible for developing and implementing regulatory strategies for the designated program to secure and maintain marketing authorization in line with business objectives, and in coordination with key internal stakeholders.Essential Functions of the job: Act as the representative of European...


  • 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...


  • Basel, Basel-Stadt, Schweiz Abbott Laboratories Vollzeit

    THE POSITION:This role of is the senior most regulatory role within EPD in the Emerging Market business unit_. _As a leader, the role of the Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to support and partner the business by ensuring the successful development, manufacture and distribution of products in...


  • Basel, Basel-Stadt, Schweiz Stratpharma Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Manager, Regulatory Affairs,...


  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Global Regulatory Affairs...


  • Basel, Basel-Stadt, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: PermanentClosing date:Reference: VN1710 Who we are Vectura Fertin Pharma's ambition is to become a marketleading wellness and healthcare business.Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. We are...


  • Basel, Basel-Stadt, Schweiz unisite AG Vollzeit

    Die Gesundheit und die Lebensqualität von Patienten zu verbessern, ist das Ziel des forschenden Pharmaunternehmens Boehringer Ingelheim. Seit der Gründung im Jahre 1885 in Familienbesitz, zählt Boehringer Ingelheim zu den 20 führenden Unternehmen der Branche. Für die drei Geschäftsbereiche Humanpharmazeutika, Tiergesundheit und Biopharmazeutika...


  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Associate Director Global...


  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Associate Director Global...


  • 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...


  • 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...


  • Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    General Description:Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...


  • Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz Global Personal Partner Vollzeit

    EINFÜHRUNG:Our profession and our passion are "HR Management".Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland.For our client, an international technology company in Basel, we are looking for...


  • Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

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