Senior Manager Regulatory Affairs

4 days ago


Chicago, Illinois, United States AbbVie Full time
Job Summary

We 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 Responsibilities
  • Develop and implement regulatory strategies for assigned products in the US and Canada, ensuring compliance with relevant regulations and guidelines.
  • Collaborate with cross-functional teams to ensure effective implementation of regulatory strategies and ensure alignment with business objectives.
  • Provide regulatory expertise and guidance to internal stakeholders, including commercial, clinical development, and public affairs.
  • Prepare and review regulatory submissions, including responses to health authority inquiries and registration maintenance.
  • Develop and maintain relationships with health authorities, including the FDA, to ensure effective communication and collaboration.
  • Stay up-to-date with changing regulatory requirements and guidelines, and provide recommendations for updates to regulatory strategies and procedures.
Requirements
  • 6+ years of experience in regulatory affairs, with a strong background in pharmaceutical regulatory activities.
  • Advanced degree in a relevant field, such as pharmacy, biology, chemistry, or pharmacology.
  • Excellent negotiation, problem-solving, and communication skills, with the ability to build consensus and deliver challenging messages effectively.
  • Proven track record of implementing successful regulatory strategies and experience working in a complex and matrix environment.
What We Offer

AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) eligibility. This role is eligible to participate in our short-term and long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



  • 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...


  • Chicago, Illinois, United States Adtalem Global Education Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Adtalem Global Education. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring our institutions operate in compliance with federal and state regulations and internal policies.Key ResponsibilitiesProvide advanced regulatory...


  • 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...


  • Chicago, Illinois, United States Adtalem Global Education Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Adtalem Global Education. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with federal, state, and internal regulations.Key ResponsibilitiesRegulatory Compliance: Interpret and apply statutes, regulations, and...


  • Chicago, Illinois, United States Northern Trust Full time

    About Northern TrustNorthern Trust is a leading global financial institution with a rich history dating back to 1889. As a Fortune 500 company, we have established ourselves as a trusted partner for individuals, families, and institutions seeking innovative financial services and guidance.Our commitment to service, expertise, and integrity has enabled us to...


  • Chicago, Illinois, United States Randstad Full time

    Job Summary:As a leading staffing and recruitment agency, Randstad is committed to finding top talent for the life sciences industry. We are seeking a highly skilled Regulatory Affairs Submission Manager to join our team.This role offers a unique opportunity to work with a research-driven biopharmaceutical company that has developed 32 groundbreaking...


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

    Job SummaryWe are seeking a highly skilled Associate Regulatory Affairs Submission Management to join our team at US Tech Solutions.The successful candidate 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...


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

    Job Title: Associate Regulatory Affairs Submission ManagementAbout the Role:We are seeking an experienced Associate Regulatory Affairs Submission Management professional 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...


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

    US Tech Solutions is seeking a skilled Regulatory Affairs Submission Management professional to join our team. The ideal candidate will have experience managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams. Key responsibilities include: * Collaborating with regulatory submission teams to ensure...


  • Chicago, Illinois, United States The Ferrara Candy Company Full time

    Job SummaryWe are seeking a highly skilled Global Senior Regulatory Specialist to join our team at The Ferrara Candy Company. As a key member of our Regulatory Affairs team, you will be responsible for independently researching and navigating internal and external tools and systems to ensure compliance with ingredient, additive, standard of identity,...


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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Submission Management Associate to join our team at US Tech Solutions.The successful candidate 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...


  • Chicago, Illinois, United States AbbVie Full time

    Job DescriptionAbbVie is a leading global biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that solve serious health issues. We are seeking a highly skilled and experienced Director, Regulatory Affairs Global Strategy to join our team.The successful candidate will be responsible for developing and...


  • Chicago, Illinois, United States Sol-Millennium Medical Group Full time

    About Sol-Millennium Medical Group: Sol-Millennium Medical Group is a worldwide healthcare organization committed to enhancing the safety and welfare of patients and healthcare professionals. With pioneering solutions and a dedication to excellence, we aim to provide products that improve the quality of care. Our workforce is enthusiastic, motivated, and...


  • Chicago, Illinois, United States Sol-Millennium Medical Group Full time

    About Sol-Millennium Medical Group: Sol-Millennium Medical Group is a worldwide healthcare organization committed to enhancing the safety and welfare of patients and healthcare professionals. Through innovative solutions and a dedication to excellence, we aim to provide products that improve the quality of care. Our team is enthusiastic, driven, and focused...


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

    About the RoleUS Tech Solutions is seeking a highly skilled Regulatory Affairs Submission Management professional 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, ensuring timely delivery of high-quality dossiers that meet technical specifications defined by...


  • Chicago, Illinois, United States National Guard Employment Network Full time

    Job DescriptionGovernment Relations and Public Affairs OpportunityFerrara is seeking a highly skilled Government Relations and Public Affairs professional to join our team. As a key member of our Institutional Affairs & Corporate Communications team, you will play a critical role in shaping our company's strategic business priorities and promoting our...


  • Chicago, Illinois, United States Greater Chicago Food Depository Full time

    Job Title: Senior Manager of Government AffairsJoin the Greater Chicago Food Depository team as a Senior Manager of Government Affairs, where you will play a critical role in advancing the organization's legislative agenda and building relationships with local, state, and federal elected officials.About the Role:The Senior Manager of Government Affairs will...


  • Chicago, Illinois, United States Sol-Millennium Medical Group Full time

    About Sol-Millennium Medical GroupWe are a global healthcare company dedicated to improving the safety and well-being of patients and healthcare providers. Our mission is to deliver innovative solutions that enhance the quality of care.Job OverviewWe are seeking a skilled Regulatory Specialist to join our team. This role is essential for assisting the...


  • Chicago, Illinois, United States fairlife Full time

    Job DescriptionAs a key member of the fairlife team, the Senior Director, Industry Affairs and Sustainability will play a critical role in strengthening the company's reputation as a leader in animal agriculture and environmental stewardship.Key Responsibilities:Industry Partnerships: Develop and maintain relationships with key industry stakeholders,...


  • Chicago, Illinois, United States McCormack Schreiber Legal Search Full time

    Legal Advisor – UK/EU Regulatory Affairs (Fluency in German Required)Position Overview:We are collaborating with a leading global investment management firm that is seeking a seasoned regulatory and compliance attorney to take on the role of Legal Advisor. This position can be based in either Chicago or New York and focuses on the legal and regulatory...