Senior Global Regulatory Strategy Lead for Submissions
Otsuka America Pharmaceutical Inc.
A leading global pharmaceutical company in Columbia, SC is seeking an experienced regulatory affairs professional. This role involves developing regulatory strategies, managing diverse drug submissions, and collaborating with cross-functional teams. The ideal candidate must have significant experience in the pharmaceutical industry, a relevant degree, and strong communication skills. Competitive compensation and comprehensive benefits are offered. #J-18808-Ljbffr
$249.97k - $388.13k
...The Executive Director, Global Value Evidence Lead, is a strategic leader responsible... ...global value evidence strategy across the company's portfolio. This senior leader will provide... ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the...RegulatoryTemporary workLocal areaFlexible hours$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of global... ...investigational and marketed prescription drug submissions and manages lifecycle activities for... ...alignment with the Global Regulatory Lead. Translates complex pertinent global...SeniorRegulatoryTemporary workWork at officeLocal areaFlexible hours$249.97k - $388.13k
...Senior Director, Global Medical Safety physician (psychedelics), leads and supports safety team(s) in all aspects... ..., ethical and regulatory considerations associated... ...a robust safety strategy that supports accelerated... ...global regulatory submissions, including INDs, NDAs...SeniorRegulatoryTemporary 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...SeniorRegulatoryTemporary workFlexible hours$67.7k - $115.1k
...Sr. Safety & PV Submission Specialist Responsibilities Collaborate with the Sponsor and internal... ...as required Apply safety reporting regulatory intelligence maintained by Syneos Health... ...Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs,...SeniorRegulatoryContract workFlexible hours$105.79k - $141.05k
...future of AI‑ready connectivity, join us today. The Role As a SR Lead Commercial Strategist, you will play a crucial role in ensuring... ...customer‑facing teams. Your primary focus within the Commercial Strategy team is annual planning, translating business priorities, growth...SeniorTemporary workLocal area- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough... ...with Global Regulatory Leads to drive globally aligned regulatory... ...cross-functional teams and senior leadership to drive clarity... ..., process efficiency, and submission readiness. • Prepare and...SeniorRegulatoryWork at officeRemote workWork from homeWorldwide
$124k - $280k
...60% At PwC, our people in strategy consulting focus on providing... ...and experiences you need to lead and deliver value at this level... ...the entire lifecycle. As a Senior Manager specializing in... ...stablecoins, DAOs) and their regulatory, risk, and compliance implications...SeniorRegulatoryFull timeContract workH1b$100k - $150k
...commercial insurance? Join us and lead the charge in shaping next-... ...what is possible. The Senior Product Specialist serves as... ...Ensure all products meet regulatory, compliance, and quality standards... ...Support business segment strategies; Identify opportunities for...SeniorRegulatoryTemporary workWork at officeRemote work3 days per week- Wabtec in South Carolina is seeking a Proposal Manager to oversee the preparation of commercial proposals while ensuring their accuracy and timeliness. You will act as the primary liaison with customers, managing proposal activities and negotiating contract terms. The ...SeniorContract workRemote workRelocation package
- ...Safety team as a Senior Physician where you... ...patient wellbeing and regulatory compliance. About... ...compliance with global regulations while... ...Assisting the Project Lead/Functional Lead... ...surveillance strategy, and highlighting... ...regulatory agency submissions (Investigational new...SeniorRegulatoryInternshipWork at officeLocal areaRemote workWork from homeFlexible hours
$145k - $180k
...Senior Clinical Project Manager About... ...Inc. is a global biopharmaceutical... ...is to develop a leading global rare disease... ...Pharmacovigilance, Supply Chain, Regulatory Affairs, Quality... ...of regulatory submissions to the IRB/EC (... ..., mitigation strategies and mitigate...SeniorRegulatoryTemporary workWork experience placementLocal areaRemote workFlexible hours- ...Trane Technologies in Columbia, South Carolina, is seeking a Materials Manager to oversee planning strategy, inventory control, and material flow. The ideal candidate will have a Bachelor's degree and significant experience in materials management, focusing on lean manufacturing...Senior
$230.72k - $345k
...Job Summary The Senior Director, Biostatistics, provides... ...areas. This role leads and develops a high-performing... ..., statistical analysis strategy, modeling and simulation, regulatory submission support, advisory... ...Strong working knowledge of global regulatory and industry...SeniorRegulatoryTemporary workLocal areaFlexible hours- ...Serco is hiring a Senior Manager for Trade Compliance, a critical role that requires extensive experience and expertise in compliance... ...technical agreements. A DoD Secret security clearance is necessary to ensure compliance in a complex regulatory environment. #J-18808-Ljbffr...SeniorRegulatoryRemote work
$284.32k - $355.4k
...Pharma Co., Ltd., is a global pharmaceutical... ...the position of Senior Medical Director,... ...Clinical Research Lead for stem cell and... ...Leads and drives strategy for clinical development... ...scientific/regulatory/medical standards.... ...Experience in regulatory submissions in US; preferred...SeniorRegulatoryWorldwideFlexible hours- ...highly organized and collaborative Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical... ...excellence across clinical, submission, and post-approval activities.... ...execution, and ongoing compliance with global regulatory requirements. The ideal...SeniorRegulatoryLocal areaRemote work
- ...Senior Clinical Project Manager – Oncology/Hematology... ..., you will take a lead role in advancing Phase... ...trials, managing complex, global initiatives. You'll... ...Clinical Operations, Regulatory Affairs, Data Management... ...and risk mitigation strategies to keep projects on track...SeniorRegulatoryContract workRemote work
$125k - $155k
...Overview As the nation’s leading provider of high-quality home care services, we empower... ...Moments that transform lives. The Value Strategy & Enablement Leader is accountable for designing... ...frameworks to ensure alignment with regulatory requirements, brand standards, and payor...RegulatoryLocal areaFlexible hours- ...Job Summary: The Senior Manager, Study Start-up partners closely... ...Operations study team leading global study start-up and site activation... ...) study startup activities (strategy, plans, activities,... ...local operational, legal and regulatory requirements Build and maintain...SeniorRegulatoryLocal areaRemote work
$121k - $143k
...Senior Scheduler Columbia, SC The Nuclear Company is the fastest... ...development in America and globally. About the Role We are... ..., commissioning & testing, regulatory, and project controls teams to... ..., recommend mitigation strategies, and develop recovery plans....SeniorRegulatoryBi-weekly payContract workFor contractorsWork experience placementFor subcontractor$180.37k - $212.2k
...and with it, the future global financial system. To achieve... ...We are looking for a Senior Data Protection Engineer to lead and expand our data... ...for executing a long-term strategy that balances robust security... ...mitigate risk and ensure global regulatory compliance. What you’...SeniorRegulatoryLocal area$201.37k - $236.9k
...and with it, the future global financial system. To... ...in accordance with the regulatory requirements, you'll... ...& security audit as a senior leader within the global... ...risk profile, technology strategy, and regulatory expectations... ...(US, EMEA, APAC). Lead Coinbase’s global IT &...SeniorRegulatoryWork at officeLocal area$144k - $329.1k
...We’ll help you succeed in a globally connected powerhouse of diverse... ...to join our team and lead our AI initiatives, driving innovation... ...and excellence in AI strategy and implementation within the... ...address ethical considerations, regulatory compliance, and robust security...SeniorRegulatorySummer holidayFlexible hours$126k - $178k
...impacts millions of people globally, yet it often remains... ...objective of the Senior Product Manager, Field... ...role will be focused on leading hospital optimization... ...internal partners to align strategies. Content... ...clinical evidence, FDA regulatory approvals, and market...SeniorRegulatoryWork experience placementWork at officeNight shift$89.25k - $105k
...Job Title Senior Contracts Manager Job Description Summary... ...Procurement, Asset Services, and Global Occupier Services. Job... ...contracts. Monitor legal, regulatory and internal policy changes,... ...negotiation and risk management strategies. Advise internal clients...SeniorRegulatoryMinimum wageContract workRemote workFlexible hours$233k - $315k
...Remote Be a part of a global team that is inspired... ...vision of becoming a leading biopharmaceutical company... ...Position Summary The Senior Director, Medical Monitor... ...contributes to safety strategy execution in close... ...Clinical Operations, Regulatory, Biostatistics, and other...SeniorRegulatoryTemporary workRemote work$64 - $78 per hour
...Enterprise Risk Management Senior/Lead JOB-10046881 Anticipated Start Date July... ..., assessment, and mitigation strategies. Monitor emerging risks and escalate... ...procedures. Research industry trends, regulatory developments, and emerging risks. Identify...SeniorRegulatoryHourly payFull timeContract work$119k - $215.6k
...opportunity has been created for a Senior Manager to lead complex client engagements... ...on internal controls, regulatory compliance, risk mitigation... ...operational improvement strategies Present findings, recommendations... ...are members of Allinial Global, an accountancy and...SeniorRegulatoryWork experience placementWork at officeLocal areaRemote work- ...Strategy Lead, RWD Commercial Strategy & Innovation Company: Norstella Location: Remote... ...Norstella is a premier and critical global life sciences data and AI solutions provider... ...& Innovation The RWD Strategy Lead / Senior RWD Strategy Lead owns the front-end shaping...Full timeTemporary workLocal areaRemote workFlexible hours
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