Global Regulatory Strategy & Submissions Lead
Otsuka America Pharmaceutical Inc.
A pharmaceutical company based in Lincoln, NE seeks an experienced regulatory affairs professional to develop global regulatory strategies, manage submissions, and collaborate with project teams and health authorities. Candidates should have a strong background in regulatory submissions and excellent communication skills. This position offers competitive compensation and a comprehensive benefits package. #J-18808-Ljbffr
$249.97k - $388.13k
...Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader... ...driving the global value evidence strategy across the company's portfolio.... ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated...RegulatoryTemporary workLocal areaFlexible hours- ...Purpose: The Site and Monitoring Health Lead (SMH Lead) will apply knowledge of... ...Implements client Site and Monitoring Health strategy in alignment with applicable... ...for the trial Remains current with global regulatory requirements, has a current working knowledge...RegulatoryLocal areaRemote work
$91k - $147.2k
...Companies is recruiting for an MTST Global Finance Reporting Lead - Endomech and Energy to be located... ...will be considered as a single submission. At Johnson & Johnson,we believe... ...portfolio execution team as well as the Strategy and Transformation Operating Committee...SuggestedFull timeTemporary workLocal areaRemote workWorldwide- ...Strategy Lead, RWD Commercial Strategy & Innovation Company: Norstella Location: Remote, United States Date Posted: Jun 1, 2026... ...Description About Norstella: Norstella is a premier and critical global life sciences data and AI solutions provider dedicated to...SuggestedFull timeTemporary workLocal areaRemote workFlexible hours
$124.4k - $207.4k
...Manager, IIS Prostate Cancer Strategy & Forecasting is a key strategic... ...& Strategy (IIS) team in Global Commercial Analytics and works... .... The Senior Manager plays a lead role in advising business partners... ...review and statutory or regulatory clarification, which Pfizer intends...RegulatoryPrice workPermanent employmentTemporary workH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week3 days per week- ...Parexel in Lincoln, Nebraska is seeking a Regulatory Affairs Generalist/Senior Associate to provide end-to-end regulatory support for... ...strong communication skills. Key responsibilities include managing submission processes, ensuring compliance, and collaborating with cross-...Regulatory
$249.97k - $388.13k
...Senior Director, Global Medical Safety physician (psychedelics), leads and supports safety team(s)... ...operational, ethical and regulatory considerations associated... ...a robust safety strategy that supports accelerated... ...well as global regulatory submissions, including INDs, NDAs,...RegulatoryTemporary workLocal areaFlexible hours$74.7k - $187k
...unique business, operational, and regulatory requirements of the U.S.... ...expertise to help shape product strategy, prioritize roadmap... ...key role in bringing a proven global healthcare platform to the U.... ...your potential at a company leading the way in AI and cloud solutions...RegulatoryTemporary workFlexible hours- ...with AI. What You’ll Do The Global Travel Sourcing and Operations... ...Travel Program Management and Strategy Manage KPIs and processes to... ...leadership on market dynamics, regulatory frameworks, suppliers, and... ...tools and solutions to develop leading-edge deliverables and best...RegulatoryPermanent employmentRemote workVisa sponsorshipFlexible hoursShift work
$112k
...NTT DATA is seeking an experienced BPO Director to lead strategy and performance across multiple sites in the United States. You will manage vendor relationships and drive operational excellence. The ideal candidate will have eight years of leadership experience in BPO...$100k
...Maximus is seeking a Certification Lead to manage end-to-end certification activities... ...driving process improvement and supporting regulatory-driven program objectives. **This is a... .... Support critical business strategies by monitoring the overall development, implementation...RegulatoryRemote work$249.97k - $388.13k
...visionary Senior Director, Global Clinical Development (... ...clinical development strategy across multiple... ...the clinical strategy, leading cross-functional study... ...global clinical trials and regulatory filing activities.... ...trials and regulatory submissions. • Provide medical and...RegulatoryTemporary workLocal areaFlexible hours- ...currently seeking a part-time Regulatory Affairs Consultant to... ...and health authority strategy for a major... ...development programs Lead health authority interactions... ...and manage regulatory submissions (IND applications,... ...to ICH guidelines and global regulatory pathways...RegulatoryPart timeRemote work
- ...Affairs - req1704 OVERVIEW Lead a team of clinical and technical... ...Manage clinical evidence generation strategy and implementation through... ...with multiple teams including R&D, global and local business, marketing solutions, regulatory, applications, and service....RegulatoryLocal areaRemote work
$33.63 - $50.44 per hour
...Description Bowman has an opportunity for a Lead Title Review to join our team remotely.... ...compliance with project, client, and regulatory requirements. This role reviews complex... ...for potential impacts to acquisition strategy, negotiations, or construction. Coordinate...RegulatoryWork at officeRemote work$169.4k - $279.6k
...way for best-in-class solutions. As a Lead Architect, you will collaborate with... ...execution of complex, large scale technology strategies. Leadership & Influence: Advanced... ..., responsible AI practices, and regulatory frameworks (EU AI Act, GDPR) Experience...RegulatoryTemporary workWork experience placementLocal area$79.4k - $136.4k
...Position Overview The Database Team Lead oversees the design, administration, and... ...aligned with organizational policies and regulatory requirements. Key Responsibilities... ...high availability, and disaster-recovery strategies across on-premises and cloud-hosted databases...RegulatoryContract workWork at office- ...Description M1 Global is seeking an SOC Analyst who views security as a core component... ...coordinated response. The SOC Analyst leads communication during routine and crisis events... ...Follow all SOC SOPs, post orders, and regulatory requirements Participate in drills,...RegulatoryNight shiftRotating shift
$145k
...We are seeking a Lead Consultant - Medicaid to lead advisory engagements with state... ...consultative discussions that shape client strategy, and is accountable for converting those... ...services may include: Policy & Regulatory Analysis - Evaluate and assess the operational...RegulatoryLocal area- ...initiatives utilizing Lean Six Sigma methodologies. This role will lead critical projects aimed at improving productivity and reducing... ...experience in manufacturing and will work closely with global teams. Responsibilities include analyzing data for trends, recommending...
- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science while working... ...closely with Global Regulatory Leads to drive globally aligned regulatory... ...effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic...RegulatoryWork at officeRemote workWork from homeWorldwide
- ...A leading animal health company is seeking a Regulatory Compliance Manager in Lincoln, NE. The role involves managing compliance activities with USDA, DEA, and FDA. Responsibilities include overseeing registrations, reviewing investigations into product complaints, and...RegulatoryRelocation package
- ...Otsuka America Pharmaceutical Inc. seeks a Clinical Pharmacology Lead in Lincoln, Nebraska. This role oversees all clinical... ...related to drug development phases, including study design and regulatory submissions. The ideal candidate will hold a PhD in Clinical...Regulatory
- ...alignment on the feasibility strategy, target setting, risk... ...studies Provide input into global subject/patient recruitment... ...sites and tracking systems for regulatory submissions, drug supply and use,... ...clinical trials. ~2-3+ years leading aspects of global clinical...RegulatoryRemote work
- ...Teradata Corporation (SE) is looking for a Director, Global Partner Marketing in Lincoln, Nebraska. This role involves leading the global partner marketing function and executing integrated marketing strategies across the partner ecosystem, ensuring alignment with regional...Flexible hours
$105.79k - $141.05k
...connectivity, join us today. The Role The Sr Lead Permitting Manager will play a critical... ...and are within the expectations set with regulatory requirements and corporate guidance. A... ...personal data. To review Lumen’s Global Employment Applicant and Talent Community...RegulatoryFull timeTemporary workLocal areaRemote workWork from home$67.9k - $199.14k
...The Hispanic Alliance for Career Enhancement is seeking a Sr. Manager, Strategic Planning – Broker Strategy to own Aetna's broker-led growth strategy. This role will involve defining broker segmentation, developing campaigns, and ensuring growth alignment with regional...$80.8k - $121.2k
...Summary: The Brecknell Scales Global Product Manager owns the full... ...product lifecycle and global strategy for the Brecknell Scales... ...and ROW where possible). • Lead New Product Introduction (NPI... ...regional teams. • Ensure full regulatory compliance across regions (...RegulatoryLocal areaRemote work$145k - $165k
...groundbreaking technology, we now lead 23 diverse affiliate... ...City. Fujifilm is globally headquartered in Tokyo... ...review of quotes, submissions, and other... ...Legal, IT, HR, Finance, Regulatory and other core functions... ...recommend and implement strategies to resolve compliance...RegulatoryRemote workFlexible hours- ...Resources (IBR) is seeking a Collections Operation Operational Lead in Lincoln, Nebraska. This position supervises daily functions... ...operation, ensuring that all procedures follow SOPs and comply with regulatory standards. The role involves managing donor flow, solving...RegulatoryFlexible hours
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