Regulatory Affairs Chemistry Manufacturing Lead

Há 3 dias


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

BiomRieux Bv Job Description

Overview:

We are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls to join our team at BiomRieux Bv in Lisboa. This is an exciting opportunity for a talented professional to play a key role in facilitating and implementing Regulatory CMC strategies for assigned small molecule products.

Job Summary:

The successful candidate will be responsible for the preparation and review of regulatory CMC dossiers for MSA network changes with health authorities. This includes working closely with the CMC Product Lead and managing outsourcing partners to support project execution.

Key Responsibilities:

  1. Work with the CMC Product Lead for assigned project and be accountable for the delivery of all regulatory milestones for assigned projects.
  2. Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  3. Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job SummaryBiom?Rieux Bv seeks a highly skilled Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing to provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects.


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    **Company Overview**Organon, a leading pharmaceutical company, seeks an experienced Senior Regulatory Affairs Chemistry Manufacturing Lead to join our team.**Job Description**We are looking for a highly skilled professional to provide regulatory CMC support for Organon Network Projects. As the lead, you will be responsible for overseeing preparation and...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job Description: We are seeking a highly skilled Associate Principal Scientist to join our Organon team in a Regulatory Affairs Chemistry Manufacturing role. The successful candidate will provide regulatory CMC support for Organon Network Projects, leading the preparation and submission of CMC dossiers for assigned Network Projects. They will also oversee...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job DescriptionThe PositionBiom?Rieux Bv is seeking a skilled Regulatory Affairs Chemistry Manufacturing Senior Specialist to provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects, while working alongside CMC Product Leaders, OMS Network Teams, and CMC...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job OverviewThe Organon Manufacturing & Supply (OMS) is seeking a highly skilled Associate Director, Regulatory Affairs Chemistry Manufacturing to provide regulatory support for network projects. This role will lead the preparation and submission of CMC dossiers for assigned network projects.About the RoleThis position will oversee the preparation and...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Company Overview: Organon is a leading pharmaceutical company dedicated to improving human health. We are committed to delivering innovative solutions that meet the evolving needs of our customers and patients.Salary: $120,000 - $180,000 per year, depending on experience and qualifications.Job Description:The PositionWe are seeking an experienced Senior...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    At Organon, we're committed to delivering ingenious health solutions that empower people to live their best lives. Our team is seeking a skilled Senior Regulatory Affairs Lead to oversee Chemistry and Manufacturing strategies across our Network Projects. This critical role will lead the preparation and submission of CMC dossiers, collaborating with...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Organon is seeking an experienced Associate Principal Scientist to join our team in Regulatory Affairs Chemistry Manufacturing. This role will provide critical support for Organon's Network Projects, ensuring timely and high-quality submission of CMC dossiers. The ideal candidate will have a strong background in CMC strategy, project management, and...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job OverviewThe Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing and Controls position at Organon is a key role in facilitating and implementing global regulatory strategies for small molecule products. This expert will work closely with the CMC Product Lead to ensure the successful execution of project...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our team in a key role within our Regulatory Affairs department. The ideal candidate will have a strong background in Chemistry, Manufacturing and Controls (CMC) and experience in regulatory affairs.About the RoleThe successful candidate will be responsible for developing and...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    About the RoleThe Associate Director Chemistry Manufacturing Controls Regulatory Affairs will provide regulatory support for Organon Network Projects.Key ResponsibilitiesLead CMC project timelines and oversee preparation and submission of CMC dossiers.Work alongside CMC Product Leaders and Network Teams to ensure progress towards project goals.Collaborate...


  • Lisboa, Lisboa, Portugal Mygwork Tempo inteiro

    Organon is a leading global healthcare company focused on delivering innovative health solutions for women and their families.About the RoleWe are seeking an experienced Senior Scientist to join our Regulatory Affairs team as a Senior Regulatory Chemistry Expert. This role will be responsible for implementing regulatory strategies for assigned products,...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job DescriptionSr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)The Senior Scientist in this role will be responsible for implementing Regulatory Strategies for assigned products in accordance with global regulations and defined regulatory strategies.Key Responsibilities:Provide input to global product and project regulatory...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    Job Description:At Biom?Rieux Bv, we are seeking a highly skilled Sr. Scientist, Regulatory Affairs to join our team. The ideal candidate will have a strong background in regulatory chemistry, manufacturing, and controls (CMC) and be able to develop and implement global regulatory strategies for assigned products.Key Responsibilities:Develop and execute...


  • Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

    At Biom?Rieux Bv, we are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. This role is responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidelines. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) and be proficient...


  • Lisboa, Lisboa, Portugal Organón Tempo inteiro

    Job OverviewThe position of Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing at Organon is responsible for providing regulatory support for Organon Network Projects. This includes leading the preparation and submission of Chemistry, Manufacturing & Controls (CMC) dossiers for assigned projects.Main ResponsibilitiesManage processes...

  • Scientific Expert

    4 semanas atrás


    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job Title: Scientific Expert - Regulatory Affairs LeaderAbout Organon:Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.We deliver ingenious health solutions that enable people to live their best lives. Our Vision is clear: A better and healthier every day...


  • Lisboa, Lisboa, Portugal Haleon Tempo inteiro

    At Haleon, a world-leading consumer health company, we're shaping the future of everyday health. Our mission is to improve the lives of billions of people by growing and innovating our global portfolio of category-leading brands. As a Regulatory Affairs Officer, you'll play a crucial role in ensuring compliance with laws and regulations, facilitating smooth...

  • Regulatory Affairs Director

    2 semanas atrás


    Lisboa, Lisboa, Portugal Mygwork Tempo inteiro

    Company Overview: Thermo Fisher Scientific is an inclusive employer and a member of myGwork, the largest global platform for the LGBTQ+ business community. As a leading life sciences company, we strive to make a positive impact on a global scale.Estimated Salary Range: $120,000 - $180,000 per annum, depending on experience.Job Description: We are seeking a...


  • Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Job SummaryOrganon seeks a highly skilled Regulatory Affairs Expert to join its team. As a key member of our regulatory department, you will be responsible for implementing regulatory strategies for assigned products, ensuring compliance with global regulations and guidelines.Key Responsibilities:Develop and implement regulatory strategies for assigned...