Associate Principal Scientist, Regulatory Chemistry, Manufacturing And Control

Há 3 dias

Lisboa, Portugal Organon Tempo inteiro

.Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead Lisboa Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product LeadLisboa Lisboa, Lisboa, Portugal Job Description The Position The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for- cycle maintenance submissions, original registrations, and- approval changes. The incumbent may manage a team of one to two individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an- needed basis. Responsibilities Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. 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. Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support- approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems. Provide regulatory leadership as needed to product- license/due diligence review, product divestment, and product withdrawal. Collaborate with our company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including- approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle. Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing And Control

    1 semana atrás

    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control Product Lead Lisboa Associate Principal Scientist, Regulatory Chemistry, Manufacturing and ControlProduct LeadLisboa Lisboa, Lisboa, Portugal Job Description The Position The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing And Control

    Há 3 dias

    Lisboa, Portugal Organon Tempo inteiro

    Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead Lisboa Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead Lisboa Lisboa, Lisboa, Portugal Job DescriptionThe PositionThe Associate Principal Scientist is responsible for developing and implementing Regulatory CMC...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing And Control

    Há 3 dias

    Lisboa, Portugal Organon Tempo inteiro

    Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product Lead Lisboa Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Product LeadLisboaLisboa, Lisboa, Portugal Job DescriptionThe PositionThe Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies...

  • Associate Principal Scientist, Regulatory

    2 meses atrás

    Lisboa, Portugal Organon Tempo inteiro

    Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...

  • Associate Principal Scientist, Regulatory

    1 semana atrás

    Lisboa, Lisboa, Portugal Organon Tempo inteiro

    Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...

  • Associate Principal Scientist, Regulatory

    2 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    **The Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control

    Há 1 mês

    Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionThe PositionThe Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures.  The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control

    3 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionThe PositionThe Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures.  The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for...

  • Senior Scientist, Regulatory Chemistry

    4 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    **The Position** Reporting to the Lead of the Dermatology Product Portfolio in Organon Regulatory CMC, the Sr. Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidance and defined regulatory strategies. The...

  • Senior Scientist, Regulatory Chemistry

    3 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    **The Position** Reporting to the Lead of the Dermatology Product Portfolio in Organon Regulatory CMC, the Sr. Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidance and defined regulatory strategies. The...

  • Regulatory, Cmc Business Process Specialist

    3 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    **Job Description**: **Regulatory, CMC Business Process Specialist** This position can be executed remotely or Hybrid from Portugal or from the United Kingdom **Purpose of the role** Under the guidance of the Associate Principal Scientist, Regulatory Chemistry, Manufacturing, and Controls (CMC) Business Processes Lead, you will provide support for the...

  • Senior Scientist, Safety Analysis Scientist

    Há 3 dias

    Lisboa, Portugal Johnson And Johnson Tempo inteiro

    .Senior Scientist, Safety Analysis Scientist Lisboa Senior Scientist, Safety Analysis ScientistLisboa Lisbon, Lisbon, Portugal Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the...

  • Senior Scientist, Safety Analysis Scientist

    Há 3 dias

    Lisboa, Portugal Johnson And Johnson Tempo inteiro

    Senior Scientist, Safety Analysis Scientist Lisboa Senior Scientist, Safety Analysis Scientist Lisboa Lisbon, Lisbon, Portugal Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the...

  • Senior Scientist, Safety Analysis Scientist

    Há 3 dias

    Lisboa, Portugal Johnson And Johnson Tempo inteiro

    Senior Scientist, Safety Analysis Scientist Lisboa Senior Scientist, Safety Analysis ScientistLisboaLisbon, Lisbon, Portugal Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the Medical...

  • Regulatory Affairs Specialist, Iqvia Biotech

    1 semana atrás

    Lisboa, Portugal Novasyte Tempo inteiro

    Regulatory Affairs Specialist, IQVIA Biotech Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions: - Acts as a Regulatory Team Member on...

  • Senior Scientist, Safety Analysis Scientist

    1 semana atrás

    Lisboa, Lisboa, Portugal Johnson And Johnson Tempo inteiro

    Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required...

  • Senior Scientist, Safety Analysis Scientist

    1 semana atrás

    Lisboa, Lisboa, Portugal Johnson and Johnson Tempo inteiro

    Senior Scientist, Safety Analysis Scientist Lisboa Senior Scientist, Safety Analysis ScientistLisboa Lisbon, Lisbon, Portugal Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products.The Senior Scientist SAS, in partnership with the...

  • Senior Associate Regulatory Affairs

    4 semanas atrás

    Lisboa, Portugal Grabjobs Portugal Tempo inteiro

    Senior Associate Regulatory Affairs page is loaded Senior Associate Regulatory Affairs Apply remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R-183484 Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP...

  • Senior Associate Regulatory Affairs

    3 semanas atrás

    Lisboa, Portugal Grabjobs Portugal Tempo inteiro

    Senior Associate Regulatory Affairs page is loaded Senior Associate Regulatory Affairs Apply remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R-183484 Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP...

  • Senior Associate Regulatory Affairs

    1 semana atrás

    Lisboa, Lisboa, Portugal Grabjobs Portugal Tempo inteiro

    Senior Associate Regulatory Affairs page is loaded Senior Associate Regulatory Affairs Apply remote type Flex Commuter / Hybrid locations Portugal - Lisbon time type Full time posted on Posted Yesterday job requisition id R Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will...