Current jobs related to Regulatory Affairs Specialist - Tarrytown, New York - Emerge Talent Cloud

  • Regulatory Affairs Director

    1 month ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job Title: Director, Regulatory Affairs StrategyRegeneron Pharmaceuticals is seeking a highly skilled and experienced Director, Regulatory Affairs Strategy to lead our global regulatory activities for assigned products. As a key member of our team, you will provide strategic leadership on clinical regulatory filings and regulatory leadership on project...

  • Regulatory Affairs Director

    1 week ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThe Director of Regulatory Affairs will provide strategic leadership on global regulatory activities for assigned products. Key responsibilities include providing regulatory expertise, developing strategic plans, and ensuring compliance with regulations and project timelines.Key Responsibilities:Provide interpretation of regulatory authorities'...

  • Regulatory Affairs Director

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking an experienced Associate Director Regulatory Affairs to provide leadership on global regulatory activities for our assigned products. The successful candidate will be responsible for providing regulatory leadership on project teams, interpreting regulatory authorities' feedback, and developing regulatory strategic plans.Key...

  • Regulatory Affairs Director

    2 weeks ago

    Tarrytown, New York, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at BioSpace, Inc. This is a key leadership role that will provide strategic direction and guidance on global regulatory activities for our assigned products.Key ResponsibilitiesProvide leadership on global regulatory activities, including clinical regulatory filings and...

  • Regulatory Affairs Director

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThis is an exciting opportunity to lead the work of a team advancing Regeneron's pipeline in general medicine within the Regulatory Strategy group in Regulatory Affairs.The incumbent will lead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in general medicine with a focus on cardiovascular and...

  • Executive Director, Regulatory Affairs Lead

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThis is an exciting opportunity to lead the work of a team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs.Key ResponsibilitiesLead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in the area of general medicine...

  • Associate Director Regulatory Affairs Strategy

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking an experienced Associate Director Regulatory Affairs Strategy to provide leadership on global regulatory activities for our assigned products. The successful candidate will be responsible for providing regulatory leadership on project teams, interpreting regulatory authorities' feedback, and developing regulatory strategic plans.Key...

  • Regulatory Affairs Director for Cell and Gene Therapy Technologies

    6 days ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryRegeneron Pharmaceuticals is seeking a highly experienced Regulatory Affairs Director to lead the Chemistry, Manufacturing, and Controls (CMC) non-antibody team for cell and gene therapy technologies. The ideal candidate will have a proven track record of supporting cell and gene therapy products through development and approval.Key...

  • Regulatory Compliance Manager

    1 month ago

    Tarrytown, New York, United States EPM Scientific Full time

    Job Title: Regulatory Affairs ManagerAt EPM Scientific, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our operations.Key Responsibilities:Lead and manage the...

  • Quality Assurance Specialist

    2 weeks ago

    Tarrytown, New York, United States Emerge Talent Cloud Full time

    Job SummaryThe Quality Assurance Specialist plays a critical role in ensuring the quality and safety of our products. This position is responsible for supporting the QA Manager in maintaining compliance with regulatory requirements and industry standards.The ideal candidate will have a strong understanding of cGMP requirements and be able to analyze data to...

  • Quality Assurance Specialist

    1 month ago

    Tarrytown, New York, United States Emerge Talent Cloud Full time

    Job SummaryThe Quality Assurance Specialist plays a pivotal role in our Quality & Regulatory Affairs Department, supporting QA managers in achieving and maintaining compliance for OTC drug products, medical devices, dietary supplements, and cosmetics. This individual must be data-driven and analytical, with the ability to develop and maintain effective...

  • Senior Manager, Corporate Communications

    2 weeks ago

    Tarrytown, New York, United States BioSpace, Inc. Full time

    Job SummaryThe Senior Manager, Corporate Communications will play a key role in supporting communications for Regeneron's Internal Medicine therapeutic areas, including ophthalmology, obesity, cardiovascular disease, and other emerging areas of interest. This role reports into the Senior Director and communications lead for Internal Medicine and will be an...

  • Senior Manager, Corporate Communications Specialist

    2 weeks ago

    Tarrytown, New York, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Corporate Communications to join our team at Regeneron. This role will support communications for Regeneron's Internal Medicine therapeutic areas, including ophthalmology, obesity, cardiovascular disease, and other emerging areas of interest.Key ResponsibilitiesPartner with cross-functional teams to...

  • Strategic Business Planning Director

    2 weeks ago

    Tarrytown, New York, United States BioSpace Full time

    Job Title: Associate Director, Strategic Business PlanningJob Summary:We are seeking an experienced Associate Director to lead our Strategic Business Planning team. The successful candidate will be responsible for providing strategic and operational project management excellence to our I&I GMF Therapeutic Area Heads and Medical Directors.Key...

  • Quality Enhancement Specialist

    4 weeks ago

    Tarrytown, New York, United States IAHD-Institute for Applied Human Dynamics Full time

    Job Title: Quality Enhancement SpecialistIAHD-Institute for Applied Human Dynamics is seeking a highly skilled Quality Enhancement Specialist to join our team. As a Quality Enhancement Specialist, you will be responsible for ensuring that all programs and services provided by IAHD meet the highest standards of quality and regulatory compliance.Key...

  • Underwriting Specialist

    1 month ago

    Tarrytown, New York, United States CNA Full time

    Job Title: Underwriting SpecialistCNA is seeking a highly skilled Underwriting Specialist to join our team. As an Underwriting Specialist, you will be responsible for the profitable growth of an assigned book of Healthcare Professional and General Liability business for Allied Health Facilities and Physicians.Key Responsibilities:Underwrite new business and...

  • Quality Enhancement Specialist

    2 weeks ago

    Tarrytown, New York, United States IAHD-Institute for Applied Human Dynamics Full time

    Job Summary The Quality Enhancement Specialist will ensure that all programs and services provided by IAHD meet the highest standards of quality and regulatory compliance. This role involves conducting comprehensive internal audits of documentation and practices to verify adherence to federal, state, and organizational regulations. The specialist will...

  • Associate Director, Medical Communications Specialist

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking an experienced Associate Director, Medical Communications to drive the development and alignment of our scientific communications plans for our Global Medical Affairs General Medicine Strategy.The successful candidate will have a strong background in Cardiovascular/Metabolism, Genetic Medicine, and/or Rare Disease, and will be...

  • Quality Systems Specialist

    2 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

    Job Summary: We are seeking a highly skilled Quality Systems Specialist to join our team at Regeneron Pharmaceuticals, Inc. The successful candidate will be responsible for ensuring compliance with all aspects of quality for our manufacturing site, inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials...

  • Data Analytics Manager, Medical Education

    1 month ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

    Job SummaryThe Associate Manager, Medical Education – Data Analytics, plays a pivotal role in harnessing data-driven insights to measure the impact of medical education on adult learners. This position involves collecting, assessing, and aggregating de-identified learning outcomes from grant-supported medical education activities, requiring collaboration...

Regulatory Affairs Specialist

2 months ago

Tarrytown, New York, United States Emerge Talent Cloud Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Emerge Talent Cloud. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our marketed products with regulatory requirements.

Key Responsibilities
  • Regulatory Compliance: Ensure that our products comply with relevant regulatory requirements, including FDA, HC, and EPA regulations.
  • Product Registration: Prepare and submit product registration documents, including drug, medical device, and cosmetic listings.
  • Regulatory Documentation: Maintain accurate and up-to-date regulatory documentation, including SDS compilations and state license maintenance.
  • Regulatory Database Management: Manage and maintain regulatory databases and systems to ensure accurate and timely reporting.
Requirements
  • Education: Bachelor's degree in a scientific field, such as biology, chemistry, or pharmacy.
  • Regulatory Knowledge: Strong knowledge of FDA regulations and guidance, including CFR, ISO, CPSC, and DHEA regulations.
  • Communication Skills: Excellent written and oral communication skills, with the ability to effectively present information to internal teams and external stakeholders.
  • Technical Skills: Proficiency in Microsoft Office Suite and ability to learn new software applications quickly.
Work Environment

The work environment is fast-paced and dynamic, with a focus on collaboration and teamwork. The ideal candidate will be able to work effectively in a hybrid schedule, with a mix of in-office and remote work.

Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.