Regulatory Affairs Specialist

4 weeks ago


San Francisco, California, United States Yoh Full time
Regulatory Affairs Specialist

Yoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements. The position offers a hybrid schedule and the opportunity to work with a growing company.

Key Responsibilities:
  • Plan and author drug product dossiers in CTD format for international markets
  • Manage variations for marketed products outside the United States
  • Respond to health authority information requests and comments
  • Review and assess CMC regulatory impact and provide regulatory strategy for post-approval changes
  • Participate in cross-functional teams and provide health authority requirements for initial international filings and post-approval changes
  • Facilitate the creation of foreign language labeling content to meet local health authority requirements
  • Maintain regulatory knowledge of current guidelines and regulations
Requirements:
  • Bachelor's degree in a scientific discipline or equivalent work experience
  • 3 or more years of Regulatory experience or related field
  • Self-starter with strong organizational skills and attention to detail
  • Background in manufacturing, research and development, or quality assurance
  • Strong communication and problem-solving skills


  • San Mateo, California, United States Collabera Full time

    Job Title: Regulatory Affairs SpecialistCollabera is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Perform data entry and maintenance of...


  • San Diego, California, United States Ajinomoto Bio-Pharma Full time

    Regulatory Affairs SpecialistAjinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.Key Responsibilities:Collaborate with internal team members to maintain compliance with...


  • San Francisco, California, United States Cala Health Full time

    About Cala HealthCala Health is a pioneering medical technology company dedicated to freeing people from the burden of chronic disease. Our innovative solutions have empowered thousands of individuals to regain control over their lives with confidence and ease.The OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic...


  • San Diego, California, United States CorDx Full time

    At CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...


  • San Mateo, California, United States RICEFW Technologies Full time

    Job Title: CMC Regulatory Affairs Data Entry SpecialistFoster City, CAJob Summary:RICEFW Technologies is seeking a highly skilled CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA...


  • San Diego, California, United States Dexcom Full time

    About the Role:Dexcom is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Specialist, you will play a critical role in preparing, submitting, and gaining regulatory approvals for our life-changing products, therapies, and customers around the world.Key...


  • San Francisco, California, United States Volt Full time

    Job Title: Regulatory Affairs Specialist II - Medical DeviceVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...


  • San Diego, California, United States ACON Laboratories Full time

    Senior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...


  • San Francisco, California, United States Mantell Associates Full time

    Mantell Associates is partnering with a mid-size Biotech company specializing in Radiopharmaceuticals and Oncology. They seek a Regulatory Affairs expert to lead the Regulatory group, driving growth and hands-on involvement.Key Responsibilities:Lead and oversee the Regulatory Affairs team, including hiring, management, motivation, coaching, and...


  • South San Francisco, California, United States AbbVie Full time

    Job Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies to ensure...


  • San Diego, California, United States Neurocrine Biosciences Full time

    Job Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...


  • South San Francisco, California, United States AbbVie Full time

    Job Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our global development teams.Key Responsibilities:Develop and implement regulatory strategies for assigned products or...


  • San Diego, California, United States Abbott Laboratories Full time

    Join Abbott Laboratories as a Regulatory Affairs Specialist IIAt Abbott Laboratories, we are committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We are...


  • San Diego, California, United States DivIHN Integration Inc Full time

    At DivIHN Integration Inc, we're seeking a skilled Regulatory Affairs Specialist to join our team. This is a unique opportunity to make a meaningful impact in the field of regulatory affairs.About the Role:This position will play a crucial role in coordinating change order reviews, allowing our full-time RA professionals to focus on key strategic...


  • San Diego, California, United States Abbott Laboratories Full time

    At Abbott Laboratories, we're seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you'll play a critical role in ensuring compliance with US, EU, and international regulations and standards for our diagnostic products.Key Responsibilities:Provide regulatory support for diagnostic...


  • San Mateo, California, United States Collabera Full time

    Job Title: Regulatory Affairs Assistant - IIJob Summary:We are seeking a highly skilled Regulatory Affairs Assistant - II to join our team at Collabera. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry, RIM System, and ensuring the completeness, correctness, and consistency of data.Key Responsibilities:Perform...


  • San Francisco, California, United States Stirling Q&R Full time

    We are seeking a highly skilled Senior Regulatory Affairs Manager to lead our client's regulatory efforts in the San Francisco Bay Area.Key ResponsibilitiesDevelop and execute global regulatory strategies for assigned products throughout their lifecycle.Provide regulatory guidance to cross-functional teams on a wide range of issues.Anticipate and resolve...


  • San Diego, California, United States BD (Becton, Dickinson and Company) Full time

    Job Description SummaryAs a Senior Specialist in Regulatory Affairs, you will play a critical role in supporting the development, sustainment, and end-of-life activities of Medical Devices and Non-Medical Devices, as well as associated Software and Accessories, on a global basis from a Regulatory Affairs standpoint.About the RoleThis fully remote position...


  • San Francisco, California, United States Stirling Q&R Full time

    Job OverviewStirling Q&R is seeking an accomplished and results-driven Senior Manager of Regulatory Affairs to lead the efforts in developing and executing regulatory strategies for our client's product portfolio.Key Responsibilities:Develop and execute global regulatory strategies for assigned products throughout their lifecycle.Provide regulatory guidance...


  • South San Francisco, California, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing regulatory strategies to facilitate the progress of assigned...