Regulatory Affairs Specialist

3 weeks ago


King of Prussia, Pennsylvania, United States PAREXEL Full time

Job Summary

PAREXEL is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the timely performance of work within a project scope to the quality expectations of PAREXEL and our clients.

Key Responsibilities

  • Manage and coordinate the local regulatory submission strategy for clinical trials in Brazil.
  • Review critical technical documents to ensure regulatory compliance for clinical trial applications.
  • Coordinate and manage the flow of information, track project progress, and identify and solve problems in a team-oriented environment.

Requirements

  • Experience in compiling and submitting documentation to local MOH (Anvisa) is mandatory.
  • Good English skills are necessary.
  • Experience in supporting Clinical Trials is required.

About PAREXEL

PAREXEL is a leading global biopharmaceutical outsourcing company. We provide a comprehensive range of solutions to help our clients succeed in the highly competitive pharmaceutical and biotechnology industries.



  • King of Prussia, Pennsylvania, United States PAREXEL Full time

    Parexel Croatia is seeking an experienced Regulatory Affairs Specialist to provide operational and business clinical trials regulatory consultancy to clients. The ideal candidate will possess a university degree in a life science discipline, significant CRO/Pharma experience within Regulatory, and fluency in English and the local language. Key...


  • King of Prussia, Pennsylvania, United States Exelixis Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Policy Specialist to join our team at Exelixis. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices.Key ResponsibilitiesEnsures timely preparation and completion of action plans to maintain Exelixis...


  • King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:Exelixis is seeking a highly skilled Regulatory Affairs Policy Specialist to join our team. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices. This includes ensuring timely preparation and completion of action plans to maintain Exelixis processes and...


  • King of Prussia, Pennsylvania, United States PAREXEL Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team in Romania. This role can be either home or office based in Bucharest.As a Senior Regulatory Affairs Associate, you will bring a few years of Regulatory Affairs experience gained in the industry. You will have experience in Clinical Trial Applications (CTA) from various...


  • King of Prussia, Pennsylvania, United States Exelixis Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director, Commercial Regulatory Affairs to join our team at Exelixis. This role will be responsible for providing strategic regulatory leadership in the areas of advertising and promotion, ensuring compliance with all FDA regulations, and providing regulatory guidance on the review and...


  • King of Prussia, Pennsylvania, United States CSL Behring Full time

    The Senior Director, Global Medical Affairs Pipeline Hematology is a key member of the Therapeutic Area Leadership Team (TALT), contributing to the cross-functional development of TA strategies and individual global product strategies.Main Responsibilities & AccountabilitiesOversees and directs pipeline TA Medical Directors' activities in developing and...


  • King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    Parexel International Corporation busca um especialista em questões regulatórias para trabalhar em projetos de desenvolvimento de medicamentos e dispositivos médicos. O candidato deve ter experiência em revisão de documentos e procedimentos de registro de produtos.Responsabilidades:Revisar e atualizar procedimentos de registro de produtos;Trabalhar em...


  • King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job SummaryThe Senior Director, Head of Medical Affairs, LatAm & Partner Business will provide strategic, operational, and medical leadership for a high-performance Medical Affairs organization across the CSL Behring responsible cluster, supporting ~$0.9B in revenue. This is a critical role to drive medical strategy and execution excellence for a critical...


  • King of Prussia, Pennsylvania, United States Regulatory DataCorp, Inc. Full time

    RDC, a leading provider of Anti-Money Laundering, Know Your Customer, Anti-Bribery & Corruption solutions, is seeking a skilled Security Analyst to protect its clients from regulatory risks.The ideal candidate will have 1-3 years of experience in information security, with a strong understanding of threat models, methodologies, and industry compliance...


  • King of Prussia, Pennsylvania, United States CSL Behring Full time

    The Senior Director Medical Affairs Inline Bleeding will provide strategic medical leadership across all inline bleeding products. This role is critical to drive medical strategy and execution excellence, enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement, and product expertise.Main Responsibilities &...


  • King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job SummaryThe Senior Director Medical Affairs Inline Bleeding will provide strategic medical leadership across all inline bleeding products. This role is critical to drive medical strategy and execution excellence, enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement, and product expertise.Main...


  • King of Prussia, Pennsylvania, United States Regulatory DataCorp, Inc. Full time

    Job SummaryRegulatory DataCorp, Inc. is seeking a skilled QA Automation Engineer to contribute to the Quality Control team. As a QA Automation Engineer, you will be involved in all phases of the software lifecycle, from planning to post-deployment testing. We are looking to expand our automated testing capabilities, so if you're passionate about test...


  • King of Prussia, Pennsylvania, United States Regulatory DataCorp, Inc. Full time

    Job SummaryRegulatory DataCorp, Inc. is seeking a skilled QA Automation Engineer to join our Quality Control team. As a QA Automation Engineer, you will be involved in all phases of the software lifecycle, from planning to post-deployment testing. We are looking to expand our automated testing capabilities, so if you're passionate about test automation, we...


  • King of Prussia, Pennsylvania, United States Vaco Full time

    About the Role:The Environmental Approvals Specialist is responsible for ensuring compliance with regulatory requirements and overseeing the approval process for various projects and initiatives. This role requires a strong understanding of environmental regulations and procedures, as well as excellent communication and organizational skills.Key...


  • King of Prussia, Pennsylvania, United States Aequor Technologies Full time

    Job SummaryAs a Senior Biostatistics Director at Aequor Technologies, you will lead late phase project and regulatory submissions, representing Biostatistics in interactions with regulatory authorities. You will define statistical strategy and ensure appropriate statistical methodologies are applied to study design and analysis for clinical trials.Key...


  • King of Prussia, Pennsylvania, United States Clean Earth Holdings Full time

    Job DescriptionThe Regional Account Manager will be responsible for expanding the Company's business within pre-assigned territories. This position is accountable for achieving sales goals through the acquisition and development of new customers and expansion of the product line within the existing customer base.Key ResponsibilitiesMaintains current...


  • King of Prussia, Pennsylvania, United States Arka Service Full time

    Job Title: Cybersecurity SpecialistJob Summary:Arka Service is seeking a highly skilled Cybersecurity Specialist to join our team. As a Cybersecurity Specialist, you will be responsible for ensuring the security and integrity of our systems and data. This is a challenging and rewarding role that requires a strong understanding of cybersecurity principles and...


  • King of Prussia, Pennsylvania, United States BioSpace, Inc. Full time

    Job Title: Director, US Marketing HizentraCSL Behring is seeking a highly skilled and experienced Director, US Marketing Hizentra to lead the development and execution of marketing strategies to achieve business objectives and goals for chronic inflammatory demyelinating polyneuropathy (CIDP).Key Responsibilities:Develop and implement comprehensive marketing...


  • King of Prussia, Pennsylvania, United States Enviri Corporation Full time

    Job DescriptionClean Earth is a leading provider of environmental services in the United States, offering remediation, disposal, recycling, and beneficial reuse solutions for hazardous and non-hazardous waste, contaminated soil, and dredged material.As a Regional Account Manager, you will be responsible for expanding the Company's business within...


  • King of Prussia, Pennsylvania, United States PAREXEL Full time

    Job SummaryWe are seeking a highly skilled Pharmaceutical Services Specialist to join our team at PAREXEL. As a key member of our Pharmaceutical Services team, you will play a critical role in the conduct of Phase I studies, ensuring compliance with ICH Good Clinical Practice (GCP) and local regulatory requirements.Key ResponsibilitiesMaintain accurate and...