Regulatory Affairs Director

hace 1 mes


Barcelona, Barcelona, España Sandoz A tiempo completo
Job Description

As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department. Your primary responsibility will be to drive and deliver high-quality documentation to support successful submissions, adhering to agreed timelines and project plans. This includes preparing registration documentation and assessing the appropriateness of registration documentation for active ingredients/intermediates.

Key Responsibilities
  • Lead, coach, and mentor associates to ensure sufficient training and development opportunities, maximizing regulatory competence.
  • Take responsibility for financial targets, including cost center responsibility.
  • Ensure timely and accurate reporting of regulatory activities.
  • Analyze group performance and make recommendations for improvement.
  • Coordinate the preparation and execution of regulatory documents, ensuring compliance with current global regulatory standards.
  • Formulate and drive global regulatory strategy, balancing business benefit with regulatory compliance.
  • Generate, review, and approve internal regulatory guidance documents, protocols, and reports within assigned projects.
  • Establish and maintain sound working relationships with colleagues, partners, and customers.
  • Provide regulatory guidance to cross-functional teams and determine regulator impact for changes in chemistry, manufacturing, and control procedures.
  • Support or lead global regulatory projects/initiatives.
  • Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions and for new technical trends.
  • Transfer knowledge and experiences to the organization.
  • Liaise with regulatory agencies and represent the company in regulatory meetings and discussions.
Requirements
  • PhD in a natural science (chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related post-doctoral/industrial experience or Master/BSc in a natural science with at least 3 years of work-related experience, including people management experience.
  • Leadership experience within the regulatory affairs function.
  • Broad knowledge of Module 3 and regulatory guidelines.
  • Good knowledge of relevant software tools.
  • Good skills in presentation and scientific/technical writing.
  • Good documentation skills and ability to understand and follow written procedures.
  • Fluent oral and written English and Spanish.


  • 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 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 Sandoz A tiempo completo

    Job SummaryAs 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 objectives.Key...


  • Barcelona, Barcelona, España Innovaderm Research A tiempo completo

    Job SummaryThe Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department to ensure compliance with Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing strategic guidance on regulatory activities, overseeing the performance of direct reports, and...


  • 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 Healthcare Businesswomen'S Association A tiempo completo

    Job Description:As a Regulatory Affairs Associate Director, 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 Responsibilities:Lead, coach, and mentor associates to ensure sufficient...


  • 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...


  • Barcelona, Barcelona, España Sandoz A tiempo completo

    Job DescriptionAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's products comply with global regulatory standards. Your key responsibilities will include:Leading and mentoring a team of regulatory associates to drive high-quality documentation and...


  • 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

    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 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 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 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 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 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 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 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...