Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Submissions Lead - RA Operations

BioSpace

AbbVie is seeking a Senior Associate, Regulatory Affairs Submission Management to lead medium to high impact submission projects, coordinating with cross‑functional teams across Development, Marketing, and post‑marketing regulatory activities. You will establish and maintain submission content planners, manage timelines, run team meetings, and interact with publishing vendors while ensuring compliance with regulatory guidance and quality standards. #J-18808-Ljbffr BioSpace

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Submissions Lead - RA Operations in North Chicago, IL vacancy
  •  ...Instagram, X and YouTube. Position Title Senior Associate, Regulatory Affairs Submission Management Job Description The...  ...by a regulatory agency. Acts as RA Submissions interface with project...  ...R&D/support, Scientific affairs, operations or related area. Experience in... 
    Operations
    Senior
    Regulatory
    Temporary work
    Work at office
    Remote work

    BioSpace

    North Chicago, IL
    3 days ago
  • Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing...  ...content strategy for regulatory submissions (INDs/CTAs, amendments, new...  ...within Regulatory Affairs, Operations and R&D, and represents CMC...  ...; participates in RA CMC internal initiatives; represents... 
    Operations
    Senior
    Regulatory
    Work at office
    Remote work

    AbbVie

    North Chicago, IL
    5 days ago
  •  ...Allergan Aesthetics portfolio. Senior Manager, Regulatory Affairs - Chemistry,...  ...content strategy for regulatory submissions (INDs/CTAs, amendments, new...  ...across Regulatory Affairs, Operations, and R&D. The Senior...  ...department; participate in internal RA CMC initiatives to drive... 
    Operations
    Senior
    Regulatory
    Work at office
    Remote work

    BioSpace

    North Chicago, IL
    5 days ago
  • Job Description Senior Director of Regulatory Business Excellence is accountable to lead a cross‑functional team of Business Process...  ..., especially within R&D, RA, and Operations. The Senior Director will...  ...success of ongoing key submission support programs and ensuring... 
    Operations
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  •  ...in the United States is seeking a Senior Manager, Combination Products & Medical Devices to lead QA across development, design controls, and regulatory compliance for combination...  ...functional teams, coordinate with R&D, Operations QA, RA, and supply chain, and oversee supplier... 
    Operations
    Senior
    Regulatory

    AbbVie

    North Chicago, IL
    5 days ago
  • $160.5k - $305k

     ...Description The Director I Regulatory Affairs, Chemistry,...  ...manages regulatory submissions including INDs/CTAs, amendments...  ...areas and the Operations and Research & Development...  .... Represents RA CMC on product development...  ...for agency meetings and lead CMC discussions for... 
    Operations
    Regulatory

    AbbVie

    North Chicago, IL
    5 days ago
  • BioSpace is seeking a Manager for Regulatory Affairs focusing on Chemistry Manufacturing & Controls (CMC). This role involves preparing regulatory strategies, managing product submissions, and representing CMC on development teams to ensure compliance with regulations.... 
    Regulatory

    BioSpace

    North Chicago, IL
    2 days ago
  •  ...Aesthetics portfolio. Purpose Lead the management of GCP quality...  ...processes and supporting the submission‑ready data of therapies....  ...programs. Interact with Development Operations and supporting functions to...  ...in GCP quality assurance, regulatory affairs, clinical development... 
    Operations
    Senior
    Regulatory
    Local area

    BioSpace, Inc.

    North Chicago, IL
    7 hours ago
  • AbbVie Development Sciences is seeking a Strategy Lead, Submission Automation to shape the automation roadmap for dossier submissions (INDs...  ...modalities. You will partner with dossier management, Regulatory Affairs, and IT to translate reporting needs into scalable automation... 
    Regulatory

    Allergan

    North Chicago, IL
    2 days ago
  • AbbVie is seeking a Strategy Lead for Submission Automation in the Development Sciences Data & Digital Strategy group. You will shape the...  ...BLAs) across modalities, partnering with dossier management, Regulatory Affairs, and IT. The role emphasizes scalable automation,... 
    Regulatory

    AbbVie

    North Chicago, IL
    2 days ago
  • $124.5k

     ...Primarily responsible for leading the management of GCP quality...  ...audit program with the goal of submission-ready quality data, first...  ...Interact with Development Operations organization and supporting...  ...in GCP quality assurance or regulatory affairs or clinical development... 
    Operations
    Senior
    Regulatory
    Local area

    AbbVie

    North Chicago, IL
    3 days ago
  • AbbVie is seeking a seasoned RSM Regulatory Lead to develop, implement, and maintain restricted substances management programs in line with EU RoHS, EU REACH, and US Prop 65 requirements. You will coordinate across RSM teams and external partners to ensure compliance, lifecycle... 
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    1 day ago
  •  ...Chicago, IL is seeking an Associate Director of Biopharmaceutics to lead a team applying in vitro dissolution tools, in silico modeling,...  ..., collaborate with Discovery, DMPK, Clinical Pharmacology, and Regulatory teams, and translate biopharmaceutics insights into actionable... 
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  • A leading pharmaceutical company is looking for an Associate Director of Statistics to manage statistical aspects of clinical...  ...pharmaceutical industry. Key responsibilities include leading regulatory submissions and collaborating across departments to drive innovative... 
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  •  ...capabilities. Role Overview As Strategy Lead, Submission Automation, you will shape and advance...  ...management, Development Sciences, Regulatory Affairs, and IT to understand current‑state...  ...Worcester, MA. Reports directly to the Senior Director, Development Sciences Data &... 
    Regulatory
    3 days per week

    AbbVie

    North Chicago, IL
    3 days ago
  • ICU Medical in Lake Forest, Illinois, is seeking a Regulatory Affairs professional to provide expertise in the registration of medical devices. The role involves supporting the creation of global regulatory strategies, ensuring compliance, and acting as a liaison with... 
    Senior
    Regulatory

    ICU Medical

    Lake Forest, IL
    4 days ago
  •  ...professional to develop and implement innovative clinical data solutions. You will play a crucial role in ensuring data integrity and regulatory compliance while mentoring team members. This position requires a Bachelor's degree and at least 5 years of experience in... 
    Senior
    Regulatory

    Allergan

    North Chicago, IL
    2 days ago
  •  ...worldwide. Products include regulatory starting materials, Active Pharmaceutical...  ...processes. AbbVie Operations Quality Assurance is seeking a Product Quality Manager to lead quality deliverables for late...  ...lead to support regulatory submission by developing, reviewing and... 
    Operations
    Senior
    Regulatory
    Contract work
    Local area
    Worldwide

    AbbVie

    North Chicago, IL
    5 days ago
  •  ...knowledge of compliance and regulatory requirements. Oversee project...  .... Along with Clinical Operations, oversee study enrollment and...  ...Clinical Study Reports, regulatory submissions and other program documents....  ...communication skills. Senior Medical Director Qualifications... 
    Operations
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  •  ...seeking an experienced Clinical Data Strategy professional to lead data standards and delivery of clinical systems in North Chicago...  ...knowledge of CDASH/SDTM. You will mentor teammates and help shape regulatory-compliant data practices within a collaborative team. #J-18808... 
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    2 days ago
  •  ...combined experience, including at least 3 years in Quality Assurance Operations Management. Responsibilities include implementing global quality assurance strategies and managing regulatory submissions in the pharmaceutical sector. A comprehensive benefits package and... 
    Operations
    Regulatory

    AbbVie

    North Chicago, IL
    5 days ago
  •  ...Position: Senior Compliance Analyst Location: Chicago, IL Duration: 9 Months Job Description...  ...execute compliance activities across regulatory and technology control environments....  ...for ensuring adherence to key regulatory, operational, and security requirements through control... 
    Operations
    Senior
    Regulatory

    Spectraforce Technologies

    North Chicago, IL
    2 days ago
  • AbbVie is seeking a Sr. Counsel, Legal Operations in North Chicago, Illinois. This role partners with cross-functional teams to provide...  ...ensuring compliance. Key responsibilities include advising on regulatory matters, drafting and negotiating various legal agreements, and... 
    Operations
    Senior
    Regulatory

    AbbVie

    North Chicago, IL
    5 days ago
  •  ...D functions, Science and Technology, Operations QA, Supply Chain, RA and other R&D QA functions; interact...  ...Operations Directors and external customers. Lead complex global cross‑functional...  ...are in compliance with internal and regulatory agency standards. Identify gaps in... 
    Operations
    Senior
    Regulatory
    Local area
    Worldwide

    BioSpace

    North Chicago, IL
    5 days ago
  • AbbVie is seeking a senior Regulatory Substances Manager to drive development, implementation and...  ...across EU and US markets. You will lead cross‑functional teams, shape policy, and...  ...changes. A strong track record in pharma operations is essential. #J-18808-Ljbffr AbbVie
    Operations
    Regulatory

    AbbVie

    North Chicago, IL
    1 day ago
  • BioSpace is looking for a Senior Director of Regulatory Business Excellence in North Chicago, Illinois. The candidate will lead a cross-functional team to develop and improve regulatory business processes at Abbvie, focusing on training, change management, and collaborative... 
    Operations
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  •  ...information, visit Job Description Leads the direction, planning, and...  ...knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees...  ...Study reports, regulatory submissions and responses and other... 
    Operations
    Senior
    Regulatory
    Temporary work

    AbbVie

    North Chicago, IL
    5 days ago
  • $206.5k - $393k

    Senior Scientific Director, Neuroscience Clinical Development...  ...please visit us at Leads the direction,...  ...of compliance and regulatory requirements, AbbVie’s...  ...customers, markets, business operations and emerging issues....  ...reports, regulatory submissions and responses and other... 
    Operations
    Senior
    Regulatory
    Full time

    AbbVie

    North Chicago, IL
    5 days ago
  • BioSpace is seeking a Senior Counsel to provide strategic legal guidance for business innovation at AbbVie. The role involves advising cross-functional teams, navigating regulatory complexities, and influencing business outcomes. Candidates should have at least 5 years... 
    Operations
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago
  • AbbVie is seeking a Sr Engineer, Applied AI & Engineering Platforms to lead in architecting multi-agent systems that enhance drug discovery and regulatory operations. This hands-on role emphasizes building production-grade AI solutions and compliance with GxP standards... 
    Operations
    Senior
    Regulatory

    BioSpace

    North Chicago, IL
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Submissions Lead - RA Operations. Be the first to apply!