Global Regulatory Data & Submissions Specialist
Katalyst CRO
Katalyst CRO is seeking a professional for a Regulatory Affairs position located in North Chicago. Responsibilities include supporting regional Regulatory Information Management activities, maintaining regulatory records, and ensuring compliance across markets. The ideal candidate will have a Bachelor's degree in Regulatory Affairs or related field and familiarity with Veeva systems. Strong communication skills and attention to detail are essential for this role. #J-18808-Ljbffr Katalyst CRO
- ...Lake Forest, Illinois, is seeking a Senior Pharmaceutical Recruiter. The ideal candidate will provide regulatory support for both U.S. and global medical device submissions, focusing on compliance with FDA and EU requirements. Responsibilities include preparing...Regulatory
- ...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 compensation range are provided,...Regulatory
- AbbVie seeks a Director to drive regulatory data standards and governance, ensuring data quality and interoperability... ...emphasizes ISO IDMP expertise and collaboration across global teams to enable compliant data submissions. You will lead governance processes, contribute to...Regulatory
- ...impact on people’s lives. As a Global Trade Compliance organization... ...partners to gather critical data and drive informed tariff... ...classification requests for government submissions, ensuring accuracy and... ...interpreting, and communicating regulatory and legislative updates to...RegulatoryTemporary workWorldwide
$160.5k - $305k
ABBVIE is seeking a Director of Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies ensuring market approval for products. In this role, you will lead the Global Regulatory Product Team and interface with cross-functional...Regulatory$220k - $250k
...your hard work? Lundbeck is a global biopharmaceutical company... ...SUMMARY: The Director, US Regulatory Affairs Global Strategic Labelling... ...development, regulatory submission and launch. Supports Lundbeck... ...of the Company Core Data Sheet, in conjunction with Global...RegulatoryTemporary workWork at officeRemote workFlexible hours- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies, lead the GRPT, and collaborate with cross‑functional teams to secure and maintain product approvals. The role requires 5+ years in regulatory...Regulatory
- AbbVie seeks a Senior Manager, Regulatory Strategic Planning, to deliver project management capabilities for Global Regulatory Product Teams. You will lead cross-functional teams, develop schedules and milestones, and drive process improvements to enhance regulatory compliance...Regulatory
- AbbVie is seeking a Director I Regulatory Affairs located in North Chicago, Illinois. This role involves preparing CMC regulatory strategies, managing regulatory submissions, and advising on regulatory matters. The candidate should have a Bachelor's degree and significant...Regulatory
- A global biopharmaceutical leader is seeking an Associate Director for Global Quality and Compliance Excellence. This role involves leading regulatory inspections, ensuring compliance across facilities, and advancing a strong quality culture. Candidates should have a strong...Regulatory
- 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
$105.1k - $150.1k
Cardinal Health is seeking a Regulatory Affairs Manager for Global Labeling Compliance in Waukegan, Illinois. In this role, you will oversee the end-to-end alignment of medical device labeling to meet international regulations and ensure compliance across all product lines...Regulatory- AbbVie seeks a compliance-focused professional to oversee global disclosure of clinical trial data, ensuring alignment with CTIS, EUDAMED, and EU regulations. You will coordinate across regulatory, clinical, and communications teams to publish records accurately and on...Regulatory
- AbbVie is seeking a senior Regulatory Substances Manager to drive development, implementation and maintenance of restricted substances management... ...chain, applying deep knowledge of RoHS and REACH while guiding global sites through complex regulatory changes. A strong track record...Regulatory
- AbbVie seeks a senior EHS leader to develop, implement, and govern global Environmental, Health, and Safety programs across assigned scope. You will drive regulatory compliance, risk reduction, and overall EHS liability minimization while supporting a safe, sustainable...Regulatory
- ...seeks an experienced EHS leader to drive the development, implementation, and global governance of Environmental, Health, and Safety programs across AbbVie sites. You will oversee regulatory compliance, monitoring, incident management, and KPI reporting to minimize risk...Regulatory
- ...and execution across a multi-asset portfolio, ensuring integrated, evidence-based plans that support global and regional HTA submissions, payer negotiations, and regulatory requirements. Provides product leadership to HEOR strategic direction for consistent with business...RegulatoryFull timeWork experience placement
$160.5k - $305k
...Job Title Director Regulatory Affairs Global Regulatory Lead (GRL I) Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Job Description...RegulatoryTemporary workWorldwide- Senior Azure Data & Insurance Technology Specialist Location: Local Candidates: Forest Lake, IL (W2 Position)... ...outcomes and operational efficiency for global insurance stakeholders. Key... ...datasets for pricing, underwriting, and regulatory reporting. Build high‑performance...RegulatoryLocal area
$274.5k
...Role Summary The Global Development Lead (GDL) represents Clinical on the Global Medicine... ...studies in support of worldwide regulatory submissions, and to develop and secure endorsement... ...target product profile(s) and clinical data review, including CRF design, signal interpretation...RegulatoryPermanent employmentLocal areaWorldwideRelocation package2 days per week- ...leads the development, implementation, and global governance of Environmental, Health, and... ...Provide global oversight of EHS regulatory compliance. Own the Global EHS Regulatory... ...program, including technical clarifications, data trending, audit metrics, and action plan...RegulatoryTemporary work
$274.5k
...Global Development Lead, Internal Medicine (MD, Sr. Director) United States - Washington... ...of studies supporting worldwide regulatory submissions. The GDL is accountable for creating, gaining... ...and communication of clinical trial data. Review and approve submission‑level safety...RegulatoryPermanent employmentH1bWorldwideVisa sponsorshipWork visaRelocation package2 days per week- MillenniumSoft Inc is looking for a Global Marketing Lead Manager based in Vernon Hills, IL. This senior-level role requires... ...including Medical Affairs and R&D. Candidates should have experience with regulatory processes and 510k submissions. #J-18808-Ljbffr MillenniumSoft IncRegulatory
- AbbVie is seeking a Senior Manager of Regulatory Strategic Planning, a role that blends scientific acumen with regulatory insight to drive global product strategies. You will manage GRPT schedules, lead cross-functional meetings, and coordinate with global stakeholders...RegulatoryWork at office
- ...Responsibilities Support regional Regulatory Information Management (RIM)... ...obligation tracking. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately... ...approval activities to maintain data integrity and compliance....Regulatory
$160.5k
...and execution across a multi-asset portfolio, ensuring integrated, evidence-based plans that support global and regional HTA submissions, payer negotiations, and regulatory requirements. Provides product leadership to HEOR strategic direction for consistent with...RegulatoryFull timeWork experience placementLocal area$165k - $185k
...your hard work? Lundbeck is a global biopharmaceutical company... ...SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the... ...intended for regulatory submissions for accuracy and compliance with... ...marketing. Assesses scientific data for proposed registration and...RegulatoryWork at officeRemote workFlexible hours- A leading healthcare company is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for Companion Diagnostics. The role entails leading global submissions and collaborating with diverse teams to ensure compliance with regulatory standards...RegulatoryRemote job
- A global staffing solutions firm is seeking a Mid-Senior level professional with expertise in Veeva Vault PromoMats and a strong Pharmaceutical background. In this role, you will facilitate regulatory meetings, provide process guidance, and contribute to the development...RegulatoryContract work
$165k - $230k
Associate Director, Global Quality and Compliance Excellence BioSpace - AbbVie - North Chicago, IL | Full‑time | Director level | Quality... ...cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global...RegulatoryFull timeTemporary workLocal area
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