Senior Regulatory Affairs Specialist

Há 1 mês


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 global regulatory strategies for assigned products.
  • Prepare and review information required for the development of regulatory CMC dossiers.
  • Collaborate with cross-functional teams to ensure product compliance.
  • Assess and communicate potential regulatory risks.
  • Manage multiple projects to ensure timely submissions.

Requirements:


  • Bachelor's or advanced degree in a science, engineering, or related field.
  • Minimum 2 years of relevant CMC experience.
  • Strong analytical and communication skills.
  • Experience with regulatory guidelines and documentation.

Preferred Qualifications:


  • Direct experience in Regulatory CMC and/or authoring of regulatory documentation.
  • Device and/or combination product regulatory experience.



  • Lisboa, Lisboa, Portugal Mastercard Tempo inteiro

    Company OverviewMastercard: Connecting the World Through Innovative Payments SolutionsWe are a global technology company in the financial services industry, operating the world's fastest payments processing network. Our mission is to make transactions safe, simple, smart and accessible for everyone, everywhere.SalaryThe estimated annual salary for this...


  • Lisboa, Lisboa, Portugal Abbvie Tempo inteiro

    Role OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at AbbVie. This role will be responsible for maintaining Marketing Authorisations and Medical Devices registrations, ensuring compliance with local legislation and corporate requirements.About the JobThis position is focused on providing regulatory support for the...


  • 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 Adecco Tempo inteiro

    Regulatory Affairs SpecialistAre you an EU Market Regulatory Affairs expert looking for a new challenge in the pharmaceutical sector? We have a fantastic opportunity for you!Key Responsibilities:Handling of all post-approval activities related to ANDAs, MAAs, ANDSs, variations/supplements, Annual Reports and deficiency letters according to regulatory...


  • Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    About the RoleWe are seeking a Clinical Trial Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.Job DescriptionIn this role, you will be a pivotal team member with regulatory...


  • Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

    Senior Regulatory Specialist Role in Sintra, PortugalWe are seeking a highly experienced and skilled regulatory affairs specialist to join our team in the pharmaceutical industry based in Sintra, Portugal.Job Summary:The ideal candidate will have extensive knowledge of EU market regulations and experience in handling post-approval activities related to...


  • Lisboa, Lisboa, Portugal Adalvo Tempo inteiro

    Adalvo, a dynamic and fast-paced company based in Portugal, seeks an exceptional Regulatory Affairs Lifecycle Process Specialist to join its team. Job SummaryThe successful candidate will be responsible for ensuring compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post-approval activities of products.About the...

  • Regulatory Affairs Expert

    4 semanas atrás


    Lisboa, Lisboa, Portugal Phiture Tempo inteiro

    Job OverviewWe are seeking a Regulatory Affairs Specialist to join our team at AbbVie. The successful candidate will be responsible for ensuring the maintenance of Marketing Authorisations and Medical Devices registrations.Key Responsibilities:Maintain Marketing Authorisations and Medical Devices registrations through variations and other regulatory...


  • Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

    Company OverviewA leading pharmaceutical company in Sintra is seeking a skilled Regulatory Affairs Specialist to join their team.Estimated SalaryThe annual salary for this role is approximately €60,000, considering the industry standards and location.Job DescriptionThis role involves handling all post-approval activities related to Abbreviated New Drug...


  • Lisboa, Lisboa, Portugal SGS Tempo inteiro

    About the RoleWe are seeking a highly experienced Lead Medical Devices Specialist - Regulatory Affairs to join our team at SGS. This is an excellent opportunity for a skilled professional to take their career to the next level and make a significant impact in the field of certification.


  • 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...


  • Lisboa, Lisboa, Portugal PharmaLex Tempo inteiro

    Job DescriptionWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at PharmaLex. This is a challenging opportunity for an individual who possesses in-depth knowledge of regulatory affairs, particularly in the area of labeling.About the RoleIn this role, you will be responsible for preparing and revising labeling documentation...

  • Regulatory Affairs Director

    1 semana 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 Buscojobs Portugal Tempo inteiro

    Buscojobs Portugal is seeking an experienced Regulatory Affairs Specialist to join our client company in Sintra. This role offers a direct contract with the client, an adequate salary commensurate with the function and experience, life insurance, health insurance, and an annual performance bonus.The ideal candidate will possess a Master's degree in...


  • Lisboa, Lisboa, Portugal Icon Plc Tempo inteiro

    Embark on a challenging career opportunity as a Regulatory Affairs Specialist at Icon Plc, a leading healthcare intelligence and clinical research organization.We are seeking an experienced individual to lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency...


  • Lisboa, Lisboa, Portugal Elanco Tempo inteiro

    About ElancoAt Elanco, we are a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We pride ourselves on fostering a diverse and inclusive work environment where diversity is the driving force behind innovation, creativity, and overall business success.Making...


  • Lisboa, Lisboa, Portugal PharmaLex Tempo inteiro

    About the RolePharmaLex is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our labelling and regulatory submissions group, you will be responsible for managing the creation and maintenance of regulatory documentation, including SmPCs, PILs, and labelling.Key ResponsibilitiesParticipate in the preparation and revision...


  • Lisboa, Lisboa, Portugal Adalvo Tempo inteiro

    Company Overview: Adalvo is a dynamic and growing company that offers an opportunity for well-suited candidates to join our energetic environment and culture.We are seeking a Regulatory Affairs Lifecycle Process Coordinator to ensure compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post-approval activities of...


  • Lisboa, Lisboa, Portugal Abbvie Tempo inteiro

    Role OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at AbbVie. In this role, you will be responsible for ensuring the maintenance of Marketing Authorisations for medicinal products and Medical Devices registrations through variations and other regulatory submissions.About the RoleThe ideal candidate will have a life...


  • 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...