Current jobs related to Regulatory Affairs Submission Management Associate - North Chicago, Illinois - US Tech Solutions

  • Regulatory Affairs Submission Manager

    3 weeks ago

    North Chicago, Illinois, United States US Tech Solutions Full time

    Job Title: Associate Regulatory Affairs Submission ManagementAt US Tech Solutions, we are seeking a highly skilled Associate Regulatory Affairs Submission Management professional to join our team.About the Role:The Associate Regulatory Affairs Submission Management will be responsible for managing low to medium impact submission projects involving multiple...

  • Regulatory Affairs Submission Manager

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job DescriptionAbbVie is seeking a highly skilled Regulatory Affairs Submission Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing medium to high-impact submission projects, ensuring timely delivery of high-quality dossiers that meet regulatory authorities' technical specifications.Key...

  • Regulatory Affairs Submission Manager

    2 weeks ago

    North Chicago, Illinois, United States US Tech Solutions Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Submission Manager to join our team at US Tech Solutions. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects, ensuring timely delivery of high-quality dossiers that meet technical specifications defined by regulatory...

  • Regulatory Affairs Submission Manager

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Submission Manager to join our team at AbbVie. The successful candidate will be responsible for managing medium to high-impact submission projects, ensuring timely delivery of high-quality dossiers that meet regulatory authority requirements.Key ResponsibilitiesManage submission projects,...

  • Regulatory Affairs Associate I

    2 weeks ago

    Chicago, Illinois, United States Collabera Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Associate I to join our team at Collabera. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects, ensuring timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities.Key...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    North Chicago, Illinois, United States Abbott Laboratories Full time

    About AbbottAbbott is a global healthcare leader that helps 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.Job SummaryWe are seeking a Senior Regulatory Affairs...

  • Senior Manager, Regulatory Affairs CMC

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job DescriptionAbbVie is a leading biopharmaceutical company that discovers and delivers innovative medicines and solutions to address serious health issues. We are committed to making a remarkable impact on people's lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care.The Senior Manager, Regulatory Affairs CMC,...

  • Senior Director Global Regulatory Affairs

    4 weeks ago

    Chicago, Illinois, United States Danaher Corporation Full time

    Job Title: Senior Director Global Regulatory AffairsAt Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.Job SummaryWe are seeking a highly...

  • Regulatory Affairs Manager

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job Title: Senior Manager, Regulatory Affairs AdvertisingJob SummaryAbbVie is seeking a Senior Manager, Regulatory Affairs Advertising to join our team. This role will be responsible for ensuring that advertising and promotion materials are accurate, competitive, and compliant with internal policies and regulations.Key ResponsibilitiesDevelop and implement...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job SummaryWe are seeking a highly skilled Senior Manager Regulatory Affairs to join our team at AbbVie. As a key member of our Global Regulatory Strategy team, you will be responsible for developing and implementing regulatory strategies for assigned products in the US and Canada.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job SummaryWe are seeking a highly skilled Senior Manager Regulatory Affairs to join our team at AbbVie. As a key member of our Global Regulatory Strategy team, you will be responsible for developing and implementing regulatory strategies for assigned products or product lines.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned...

  • Senior Director of Regulatory Affairs

    2 weeks ago

    Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time

    Job SummaryThe Senior Director of Regulatory Affairs will provide regulatory guidance for product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners.Key ResponsibilitiesThoroughly understand US regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    Chicago, Illinois, United States Tempus Full time

    Regulatory Affairs DirectorTempus is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and executing global regulatory strategies to support business objectives.Key Responsibilities:Develop and execute global regulatory strategies to support business...

  • Senior Director of Regulatory Affairs

    2 weeks ago

    Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time

    Job Title: Senior Director of Regulatory AffairsMeitheal Pharmaceuticals Inc is seeking a highly skilled Senior Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing regulatory guidance and support for the development and commercialization of our generic injectables,...

  • Senior Director of Regulatory Affairs

    2 weeks ago

    Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time

    Job Title: Senior Director of Regulatory AffairsMeitheal Pharmaceuticals Inc is seeking a highly skilled Senior Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing regulatory guidance and support for our biopharmaceutical products.Key Responsibilities:Develop and...

  • Senior Director of Regulatory Affairs Specialist

    1 hour ago

    Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time

    Job SummaryThe Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners. The successful...

  • Senior Director of Regulatory Affairs, Specialty Pharma

    2 weeks ago

    Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time

    About UsMeitheal Pharmaceuticals Inc is a pioneering company dedicated to the development and commercialization of generic injectables. With a strong presence in Chicago, we've expanded into fertility, biologics, and biosimilars, marketing over 50 FDA-approved products across various therapeutic areas. Our commitment to the Irish principle of Meitheal...

  • Senior Manager, Global Regulatory Affairs Strategy, US

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job SummaryAbbVie is seeking a highly skilled Senior Manager, Global Regulatory Affairs Strategy, to join our team in the US. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support for global development, ensuring compliance with regulatory requirements, and driving the development and...

  • Senior Manager, Regulatory Affairs Advertising Lead

    2 weeks ago

    Chicago, Illinois, United States AbbVie Full time

    Job SummaryThe Senior Manager, Regulatory Affairs Advertising is a critical role that combines scientific, regulatory, and business expertise to ensure compliance with legislation and regulations. This individual will lead a team of regulatory professionals, develop and implement strategies for promotional activities, and collaborate with cross-functional...

  • Director of Regulatory Affairs and Strategic Labeling

    7 days ago

    North Chicago, Illinois, United States BioSpace, Inc. Full time

    Job Title: Director of Regulatory Affairs and Strategic LabelingAbout the Role:We are seeking a highly skilled Director of Regulatory Affairs and Strategic Labeling to join our team at BioSpace, Inc. As a key member of our regulatory affairs department, you will be responsible for setting strategy and leading cross-functional teams to execute labeling...

Regulatory Affairs Submission Management Associate

2 months ago

North Chicago, Illinois, United States US Tech Solutions Full time

**Job Summary**

US Tech Solutions is seeking a highly skilled Associate Regulatory Affairs Submission Management to join our team. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams.

Key Responsibilities:

  • Manage submission projects from initiation to completion, ensuring timely and accurate delivery of regulatory submissions.
  • Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and clinical operations, to ensure seamless project execution.
  • Develop and maintain strong relationships with internal stakeholders, including project managers, scientists, and regulatory experts.
  • Ensure compliance with regulatory requirements and company policies, maintaining a high level of quality and accuracy in all submission-related activities.
  • Provide support to senior regulatory affairs professionals in the development and implementation of regulatory strategies and plans.

Requirements:

  • Bachelor's degree in a life science or related field.
  • Minimum 1 year of experience in regulatory affairs, preferably in a submission management role.
  • Strong understanding of regulatory requirements and guidelines, including FDA and ICH regulations.
  • Excellent communication and project management skills, with the ability to work effectively in a team environment.
  • Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.