Regulatory Affairs Associate Director

hace 1 mes


Barcelona, Barcelona, España Sandoz A tiempo completo

Job Summary:

As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring compliance with global regulatory standards. Your expertise in regulatory affairs will drive the development and implementation of regulatory strategies to support the company's business goals.

Key Responsibilities:

  • Lead a team of regulatory professionals to ensure compliance with global regulatory standards.
  • Develop and implement regulatory strategies to support business goals.
  • Coordinate the preparation and execution of regulatory documents.
  • Ensure regulatory CMC submissions are of high quality, consistent, and complete.
  • Formulate and drive global regulatory strategy to maximize business benefit balanced with regulatory compliance.
  • Generate, review, and approve internal regulatory guidance documents, protocols, and reports.
  • Establish and maintain sound working relationships with colleagues, partners, and customers.
  • Provide regulatory guidance to cross-functional teams and determine regulatory impact for changes in chemistry, manufacturing, and control procedures.

Requirements:

  • PhD in natural science (chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related post-doctoral/industrial experience or Master/BSc in natural science with at least 3 years of work-related experience including people management experience.
  • Leadership experience within regulatory affairs function.
  • Broad knowledge of regulatory guidelines.
  • Good knowledge of relevant software tools.
  • Good skills in presentation and scientific/technical writing.
  • Fluent oral and written English and Spanish.

About Sandoz:

Sandoz is a leader in the global medicines industry, touching the lives of almost 500 million patients last year. We have an ambition to do more and are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



  • Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completo

    Job Title: CMC Regulatory Affairs Associate DirectorAbout the Role: We are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our cross-functional Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will collaborate with colleagues across the globe to ensure...


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    Job Summary:As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.Key Responsibilities:• Lead, coach, and mentor...


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to...


  • Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Associate Director to join our CMC team in Barcelona, Spain.Key Responsibilities* Provide strategic, tactical, and operational expertise to project teams* Develop creative strategies to support new biological entities and novel products* Collaborate with cross-functional teams to ensure...


  • Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completo

    Job Description SummaryAs a Regulatory Affairs Associate Director at Healthcare Businesswomen'S Association, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high-quality documentation supporting successful submission, within agreed timelines and project plans.Key Responsibilities:Lead, coach, and mentor...


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    Job SummaryAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department, responsible for driving and delivering high-quality documentation to support successful submissions within agreed timelines and project plans.Key ResponsibilitiesLead, coach, and mentor associates to ensure the...


  • Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completo

    Job SummaryAt Az Farmacéutica Spain S.A, we are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will play a crucial role in delivering expert CMC regulatory input for projects spanning across the product...


  • Barcelona, Barcelona, España Innovaderm Research A tiempo completo

    The Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department at Innovaderm Research, ensuring all services are conducted according to standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing leadership on regulatory activities, planning and assigning work,...


  • Barcelona, Barcelona, España Argenta A tiempo completo

    Regulatory Affairs AssociateAt Argenta, we are seeking a highly skilled Regulatory Affairs Associate to join our team. This role will provide an excellent opportunity to work on a variety of challenging and innovative projects within the animal nutrition sector.Key Responsibilities:Manage relationships with leading players in the industry.Build up technical...


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    Job Description: As a Regulatory Affairs Senior Director of Quality, you will lead and manage a team of regulatory professionals within the Regulatory API (RAPI) department, driving the delivery of high-quality documentation to support successful submissions to regulatory authorities. Your key responsibilities include:


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    Company OverviewSandoz, a leading generics and biosimilars company, is committed to providing high-quality medicines to patients worldwide. With a strong focus on innovation and collaboration, we strive to make a positive impact on people's lives.About the RoleWe are seeking an experienced Regulatory Affairs Director to lead our global compliance efforts....


  • Barcelona, Barcelona, España Innovaderm Research A tiempo completo

    About Innovaderm ResearchInnovaderm Research is a leading organization in the field of clinical trials, and we are seeking an experienced Regulatory Affairs Director to join our team.


  • Barcelona, Barcelona, España Vetpharma A tiempo completo

    Job Summary:At Vetpharma, we are seeking a highly skilled Regulatory Affairs Associate to join our team. The successful candidate will be responsible for compiling and managing registration dossiers and coordinating submissions to health authorities until product approval and launch.Key Responsibilities:• Compile and manage registration dossiers and...


  • Barcelona, Barcelona, España W. L. Gore & Associates, Inc A tiempo completo

    About the Role: We are seeking a highly skilled Chemical Regulatory Affairs Associate to join our Fabrics team at W. L. Gore & Associates, Inc. In this role, you will focus on EMEA chemical control regulations, enabling the use, development, and movement of chemicals globally. You will work closely with government relations to understand, monitor, and shape...


  • Barcelona, Barcelona, España Argenta A tiempo completo

    Regulatory Affairs Associate RoleWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Argenta. This exciting opportunity will allow you to work on a variety of challenging projects within the animal nutrition sector.As a Regulatory Affairs Associate, you will be responsible for managing relationships with leading players in the...


  • Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo

    Job Title:Regulatory Affairs SpecialistGalderma Pharma S.A is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.The ideal candidate will have a strong...


  • Barcelona, Barcelona, España Werfen A tiempo completo

    The Regulatory Affairs department at Werfen is seeking a highly skilled Quality and Regulatory Affairs specialist to join our team in Barcelona, Spain.As a Quality and Regulatory Affairs specialist, you will be responsible for supporting the execution of pre and post-market regulatory affairs departmental functions. This includes assisting in the preparation...


  • Barcelona, Barcelona, España Galderma A tiempo completo

    Job Title: Regulatory Affairs AssociateLocation: Barcelona, Spain (hybrid)Job Description:The Regulatory Affairs Associate plays a pivotal role in delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. This position is responsible for regulatory aspects related to clinical trial regulatory...


  • Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completo

    Farmaprojects SAU is a B2B Pharmaceutical Laboratory company offering a broad portfolio of generic pharmaceutical products and value-added medicines. We are looking for a Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department.Key responsibilities include:Developing assessments and strategic regulatory plans for strategic product...


  • Barcelona, Barcelona, España Sinclair EBD A tiempo completo

    Job Details: We are seeking a highly skilled Pre-Market Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team at Sinclair EBD. The successful candidate will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.The Role: As a Pre-Market Regulatory Affairs...