Regulatory Strategy Leader — Global Submissions & Compliance
Jobleads-US
Sagimet seeks a visionary VP of Regulatory Affairs to shape global regulatory strategy and lead submissions for INDs, NDAs, and MAAs. You will be the primary liaison with FDA, EMA, and other agencies, guiding cross-functional teams to secure timely approvals and ensure regulatory compliance.
You will manage external regulatory vendors, oversee submission quality, and monitor regulatory trends to inform clinical development decisions.
#J-18808-Ljbffr Jobleads-US- Revolution Medicines is seeking a senior Regulatory Operations leader to drive global submission execution and strategy. You will lead a submissions-focused team, partner with Regulatory Affairs, Medical Writing, Quality, and Clinical Operations, and oversee external publishing...Regulatory
- ImmunEdge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory strategies across its portfolio of innovative therapeutics. You will... ...other health authorities while guiding teams through IND/CTA submissions #J-18808-Ljbffr ImmunEdgeRegulatory
- ...Gilead Sciences seeks a Director of Global Value & Access Strategy for its cell-therapy autoimmune portfolio. The role involves developing and executing... ...and commercialization, collaborating with clinical, regulatory, and commercial teams to ensure payer perspectives inform...Regulatory
$211k - $264k
Revolution Medicines is a global, commercial-state oncology company... ...Opportunity:The Director of Regulatory Affairs (Global Filing Lead)... ...development & regulatory submission activities for... ...effective & consistent regulatory strategies to enable successful filing...RegulatoryFull timeWork experience placementLocal areaWorldwide- ...Revolution Medicines seeks a Director of Regulatory Affairs to lead global regulatory filings for late-stage... ...end-to-end NDA/MAA preparation and submission, coordinating cross-functional teams... ...affairs experience including strategy role Proven track record executing...Regulatory
$302.01k - $390.83k
...believe every employee deserves a great leader. People Leaders are the cornerstone to the... ....Executive Director, PDM Product Strategy LeaderKEY RESPONSIBILITIESReporting to the... ...formulation development activities along with regulatory, supply chain, and quality strategies...RegulatoryFull timePart timeFor contractorsLocal areaWorldwide- ...in South San Francisco is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL I) to develop and implement global regulatory strategies for assigned products, guiding lifecycle management and ensuring compliance with worldwide regulations. The role leads the...RegulatoryWorldwide
$324.62k - $420.09k
...deserves a great leader. People Leaders are... ...informing regulatory decisions across... ..., Regulatory RWE Strategy and Innovation is... ...and their teams, Global Regulatory Affairs... ...programs, studies, submissions, and relationships... ...rigor, quality and compliance expected by global...RegulatoryFull timeFor contractorsLocal areaImmediate startShift work- ...Quality Lead in PDQ to shape quality assurance strategies across development and post-approval products, in a global matrix environment. You will drive CtQ framework... ...worldwide; strong data analytics and regulatory knowledge required. This role offers competitive...RegulatoryWorldwideRelocation
- ...and Tik Tok . The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing... ...and supporting teams. Ensures compliance with global regulatory... ...manager, acts as key internal leader and driver of regulatory policy...RegulatoryWorldwide
$182.1k - $338.3k
...Principal Content & Evidence Submission Strategy Lead is focused on... ...interpret external legal and regulatory landscapes, and lead cross-... ...coach, and advise teams and leaders to develop valuable solutions... ...understanding of corporate legal and compliance, including GCP, OIG...RegulatoryFull timeLocal area- ...Tue–Thurs in office. You will own end-to-end strategy, launch banking and wallet products, and lead P&L for a global payments business. Partner with... ...Development to scale revenue while maintaining regulatory compliance. Strong background in financial products, risk...RegulatoryWork at office
- ...Therapeutics seeks a Vice President / Senior Vice President, Global Development Leader to provide strategic and tactical medical leadership... ...from phase 1 through launch. You will ensure safety, regulatory compliance, and alignment with corporate goals while coordinating...Regulatory
- ...is seeking a Senior Corporate Counsel, Global Regulatory & Litigation, to guide worldwide regulatory... .... The role collaborates across Legal, Compliance, Privacy, Product, Engineering, and Finance to develop practical risk strategies and coordinate internal and external teams...RegulatoryWorldwide
$210.38k - $272.25k
...deserves a great leader. People Leaders are... ...& Contracting Strategy, Virology , you... ...products. ~ Ensure compliance with all... ...regulations and regulatory guidelines governing... ...Government Affairs, Global Value & Access/Pricing... ...and submissions for new contract...RegulatoryFull timeContract workTemporary workFor contractorsLocal area- ...Therapeutics, Inc. seeks a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to lead global regulatory strategy and oversee registrations... ...cross-functional teams to ensure high-quality submissions and strategic global regulatory input. The position...Regulatory
- ...United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small... ...and monoclonal antibodies, shaping strategies for accelerated development and successful... ...and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD,...Regulatory
$205.62k - $266.09k
...believe every employee deserves a great leader. People Leaders are the cornerstone... ...We are seeking a Director, Global Value & Access Strategy (GVAS), Cell-therapy Autoimmune. This... ...Medical Affairs, HEOR/RWE, Commercial, Regulatory Affairs and regional Access teams to...RegulatoryFull timeFor contractorsWork at officeLocal area- ...Responsibilities Direct planning and execution of highly complex global regulatory submissions and programs Partner with Regulatory Affairs Liaisons to develop and maintain global filing plans with regulatory milestones Oversee submission lifecycle execution and...Regulatory
$226.2k - $339.2k
...and an entertainment leader, home to some of the most... ..., Litigation and Regulatory DisputesSan Mateo, CA;... ...thrilling experiences to a global audience through our... ...develop a clear response strategy and workplan.Manage... ...stakeholders across Legal, Compliance, Privacy, Information...RegulatoryWorldwide- ...medical leadership for global clinical... ...across clinical, regulatory, research, quality... ...clinical development strategy aligned with... ...ensure regulatory compliance and standard procedures... ...discussions and submissions; interact with... ...investigators and opinion leaders Requirements...RegulatoryContract work
- ...Oncology is seeking a Clinical Trial Manager / Sr. CTM to drive global oncology trials from protocol through study completion. You... ...meet timeline and budget while maintaining high quality. Strong regulatory knowledge and TMF stewardship are required. Preferred onsite two...Regulatory
- ...Director to lead enterprise-wide real-world evidence strategy and innovation for regulatory decision-making. This role will establish systematic approaches... ...credible, compliant use of RWE in health authority submissions. Responsibilities Partner with therapeutic-area...Regulatory
- ...Description: The Associate Director, Portfolio Strategy & Decision Intelligence provides the... ....g., companion diagnostics, accelerated regulatory pathways, HTA frameworks, combination/... ..., Systems and Reporting), R&D Finance, Global Commercial Strategy & Operations to...RegulatoryWork at office
$203.8k - $326.1k
About UsVisa is a world leader in payments technology, facilitating... ...seeking a Director, Product Strategy & Operations to help lead the... ..., competitive dynamics, regulatory movement, and tech innovation... ...initiatives in highly matrixed global organizations.Experience building...RegulatoryFull timeWork experience placementWork at officeLocal areaFlexible hoursShift work$246.7k - $370.1k
...people and an entertainment leader, home to some of the... ...Corporate Counsel, Legal - Global Sales and Business... ...distribution, including compliance, negotiation of contracts, and strategy of different models as well... ...government affairs and regulatory developments in the region...RegulatoryRelocation package2 days per week- ...Director position leading regulatory strategy for hematology-oncology programs... ...for building and executing global regulatory strategies,... ...applications, and ensuring compliance across investigational and... ...compliance Prepare regulatory submissions including INDs, NDAs, DSURs...Regulatory
$141.1k - $262.1k
...clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.Develop strategic... ...and proactive risk-mitigation strategies to support early clinical... ...participate in intradepartmental, global, and cross-functional...RegulatoryLocal areaRelocation package3 days per week- ...Revolution Medicines seeks an Associate Director of Global Regulatory Affairs Project Management to oversee submission timelines and execution plans for oncology drug... ...programs. This role translates regulatory strategies into actionable plans, coordinating cross-functional...Regulatory
$174.7k - $324.5k
...Principal Clinical Quality Compliance and Policy Lead, you will serve... ..., translating complex global regulatory requirements into pragmatic... ...robust clinical compliance strategies that advance our groundbreaking... ...Problem Solver & Matrix Leader: You have a proven track record...RegulatoryLocal areaRelocation package3 days per week
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