Regulatory Affairs Submission Manager
4 weeks ago
We 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 Responsibilities- Manage submission projects, including planning, coordination, and execution, to ensure timely delivery of high-quality dossiers.
- Act as a liaison between regulatory affairs teams and project teams, providing guidance and communication on established submission processes and standards.
- Plan and conduct submission team meetings, expediting and managing multiple concurrent activities to meet submission timelines.
- Coordinate submission publishing with offsite publishers, ensuring all required resources are available to meet submission deadlines.
- Perform quality reviews of published output to ensure compliance with regulatory standards and health authority guidelines.
- Suggest and contribute to process improvements, including changes to software and business processes.
- Four years of pharmaceutical or industry-related experience with publishing-related software tools.
- Preferred experience in Regulatory Affairs, including regulatory submission project management and/or submission publishing.
- Proven leadership skills and presence.
AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This role is eligible to participate in our short-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.
-
Regulatory Affairs Submission Manager
4 weeks ago
North Chicago, Illinois, United States US Tech Solutions Full timeJob 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...
-
Senior Manager, Regulatory Affairs CMC
4 weeks ago
Chicago, Illinois, United States AbbVie Full timeJob 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 of Regulatory Affairs
4 weeks ago
Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full timeJob 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
4 weeks ago
Chicago, Illinois, United States Tempus Full timeRegulatory 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 Specialist
2 weeks ago
Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full timeJob 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...
-
Chicago, Illinois, United States AbbVie Full timeJob 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...
-
Regulatory Affairs Director
3 weeks ago
Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full timeJob Summary:Meitheal Pharmaceuticals Inc is seeking a highly skilled Senior Director of Regulatory Affairs to join our team. This role will provide regulatory guidance for biopharma product development and tech transfer, with a focus on biosimilars.Key Responsibilities:Develop regulatory strategies for projects and portfolios in biopharma, contributing to...
-
Quality Assurance/Regulatory Affairs Manager
3 weeks ago
Chicago, Illinois, United States Richardson Electronics Full timeJob Title: Quality Assurance/Regulatory Affairs ManagerAt Richardson Electronics, we are seeking a highly skilled Quality Assurance/Regulatory Affairs Manager to join our team. As a key member of our healthcare operations, you will be responsible for ensuring compliance with ISO 13485 and regulatory requirements.Key Responsibilities:Develop and manage the...
-
Global Regulatory Affairs Leader
4 weeks ago
Chicago, Illinois, United States ADM Full timeJob DescriptionGlobal Head of Regulatory & Scientific Affairs (RSA)Role OverviewThe Global Head of Regulatory & Scientific Affairs (RSA) is a critical leadership position responsible for overseeing the RSA function across ADM globally. This role ensures that all products comply with regulatory standards and are permissible in all markets, providing crucial...
-
Regulatory Labeling Specialist
4 weeks ago
Chicago, Illinois, United States Trinite Consulting Group Full timeJob SummaryThe Regulatory Labeling Specialist/Manager is responsible for ensuring compliance with FDA requirements for product labels and packaging. This role involves working closely with cross-functional teams to support submission, review, and product launches while maintaining ongoing compliance throughout the product lifecycle.Key...
-
Quality Assurance and Regulatory Affairs Manager
4 weeks ago
Chicago, Illinois, United States Richardson Electronics Full timeJob Title:Quality Assurance and Regulatory Affairs ManagerType:Full timeJob Responsibilities:As a Quality Assurance and Regulatory Affairs Manager at Richardson Electronics, you will be responsible for ensuring the healthcare operations comply with ISO 13485 and regulatory requirements. You will provide oversight for the development and maintenance of the...
-
Quality Assurance and Regulatory Affairs Manager
3 weeks ago
Chicago, Illinois, United States Richardson Electronics Full timeJob Title:Quality Assurance and Regulatory Affairs ManagerAbout the Role:As a Quality Assurance and Regulatory Affairs Manager at Richardson Electronics, you will be responsible for ensuring the healthcare operations comply with ISO 13485 and regulatory requirements. You will provide oversight for the development and maintenance of the quality program,...
-
Senior Director, Therapeutic Area Head
4 weeks ago
Chicago, Illinois, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly experienced Senior Director, Therapeutic Area Head - Regulatory Affairs Lead to lead the development and implementation of global regulatory strategies for our therapeutic areas. As a key member of our Regulatory Affairs team, you will be responsible for providing oversight and guidance to global regulatory leads,...
-
Regulatory Affairs Specialist
4 weeks ago
Chicago, Illinois, United States No7 Beauty Company Full timeAbout the RoleWe are seeking a highly skilled Regulatory Specialist to join our team at No7 Beauty Company. As a key member of our regulatory team, you will play a critical role in ensuring our cosmetic and OTC products are compliant with US and Canadian regulations and retailer requirements.Key ResponsibilitiesProvide regulatory and technical support to...
-
Chicago, Illinois, United States AbbVie Full timeJob 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...
-
Regulatory Affairs Specialist
4 weeks ago
Chicago, Illinois, United States Barton Staffing Solutions Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Barton Staffing Solutions. As a Regulatory Affairs Specialist, you will be responsible for overseeing and managing all regulatory activities within our organization.Key ResponsibilitiesDevelop and implement strategies to ensure compliance with local, national, and...
-
North Chicago, Illinois, United States BioSpace, Inc. Full timeJob 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 Specialist
3 weeks ago
Chicago, Illinois, United States Northwestern Memorial Healthcare Full timeThe Division Administrator plays a critical role in ensuring the financial and operational management of the division aligns with the organization's mission, vision, and values. This position is responsible for providing financial management support and analysis to inform operational decision-making throughout the year.Ensure that the overall budget...
-
Regulatory Affairs Specialist
3 weeks ago
Chicago, Illinois, United States Barton Staffing Solutions Full timeJob DescriptionOur client, a leading chemical development and manufacturing company, is seeking an experienced Regulatory Specialist to join their team in Chicago. This is an excellent opportunity for a skilled professional to take their regulatory career to the next level.Key Responsibilities:Develop and implement strategies to ensure compliance with local,...
-
Corporate Affairs Manager
3 weeks ago
Chicago, Illinois, United States Allwyn North America Full timeAbout the Role:The Corporate Affairs Manager at Allwyn North America plays a pivotal role in supporting the Vice President of Corporate Affairs in executing Allwyn's Corporate Affairs strategy. This position is key in managing relationships between Allwyn North America and the Illinois Lottery leadership team, owning governance processes, and stepping into a...