Director, Global Regulatory Strategy & Submissions
Immunocore
Immunocore seeks a Director of Regulatory Affairs, Tactical and Implementation to lead the regulatory tactical implementation team across US and EU submissions. You will mentor staff, coordinate strategies, and collaborate with Global Regulatory Leads to ensure timely, compliant fillings for Immunocore's development programs. The ideal candidate has significant drug development and regulatory leadership experience, with the ability to operate in a fast-paced, cross-functional environment and #J-18808-Ljbffr Immunocore
- AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology... ...expedited designations to major submissions, ensuring patient value and global...Suggested
- AstraZeneca seeks a Regulatory Affairs Director - Oncology to lead global regulatory strategy and submissions from Gaithersburg, MD. You will drive cross-functional teams, shape engagement with health authorities, and influence labeling across markets to accelerate patient...Suggested
- AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling. You will chair the Global Regulatory Sub-team with regional input, manage regulatory...Suggested
$186.23k - $279.35k
Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients... ...Authority interactions through major submissions and post‑approval maintenance—helping...SuggestedHourly payTemporary workLocal areaFlexible hours- AstraZeneca in the United States is seeking an Executive Regulatory Science Director, Respiratory & Immunology to lead global regulatory strategy across development stages. You will mentor RADs and engage with health authorities to accelerate approvals while ensuring strategic...SuggestedWork at officeFlexible hours
- USP seeks a Senior Director, Global Programs (Regulatory and Laboratory) to lead the growth of externally funded regulatory and laboratory programs. The role focuses on building long-term strategic partnerships with funders and partners to shape opportunities in the U.S...
$221.93k - $369.88k
...therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team for oncology... ...stakeholders, and deliver practical regulatory solutions. This role offers visible... ...related to product information, submission strategy) and work with matrix teams...Local area2 days per week3 days per week- ...This role involves developing and executing ATCC’s scientific strategy, building advanced model platforms, and ensuring alignment with... ...organizations. ATCC offers a mission-focused environment supporting global health, with a range of benefits including comprehensive...
$139.45k - $198.72k
...to fairness, integrity, and global collaboration. This belief is... ...plans to address emerging regulatory changes. This individual will... ...identify practical mitigation strategies for associated trade... ...environment with time-sensitive submissions and strict reporting deadlines...Full timeWork at officeImmediate startWorldwide- ...we deliver? Accountabilities: Vision and Strategy: Define a multi-year AI/digital... ...adoption targets, and an investment roadmap. Global Standards and Transformation: Set global... ...oversight; ensure privacy, security, and regulatory alignment across markets. Use Case to Product...Hourly payFull timeContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
$208.06k - $262.15k
...to fairness, integrity, and global collaboration. This belief is... ...implementing a global growth strategy for USP’sexternally fundedregulatory... ...scientific integrity, regulatory excellence, and evidence-based... ...the followingdirect reports:Director / Sr Manager, International regulatory...Full timeWork experience placementWork at officeWorldwide$155.52k - $233.28k
...have the platform (and sponsorship) to make it real. About Global Patient Solutions Within Global Patient Solutions, you will... ..., you will help evolve and scale our global patient engagement strategy, including complex patient solutions and Connect360, by...Hourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$218.06k - $327.09k
...Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...to role: Are you ready to set the global regulatory vision for pioneering... ..., from current stage through BLA submission, ensuring an efficient route to approval...Hourly payTemporary workStart working todayWork at officeFlexible hours3 days per week$250k - $300k
...entrepreneurial roots to our current global presence, we've grown into a... ...global leadership role in Regulatory Affairs responsible for... ...the worldwide regulatory strategy for QIAGEN's IVD (In Vitro Diagnostics... ..., including pre-market submissions, post-market surveillance,...Full timeLocal areaWorldwide$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients... ...the development of appropriate global and/or regional regulatory strategy(s) and their execution for... ...Experience leading regional development, submission and approval activities in local...Full timeLocal area- AstraZeneca is seeking a senior Medical Evidence Strategy Director within BPM RI to lead evidence strategy and governance for respiratory and... ...years in pharma evidence generation, strong leadership, and global collaboration to deliver timely, high-impact studies while maintaining...
- AstraZeneca GmbH seeks a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will shape end-to-end strategy for a therapeutic indication, lead global commercial initiatives, and align with clinical, data science, and market access...
- ...Pharmacopeial Convention (USP) in Rockville, MD seeks a Senior Director, Global Go‑to‑Market to design and govern a unified commercial... ...collaborating with regional leaders and the VP Global Sales to align strategy and execution. The role requires a senior commercial leader...Worldwide
$208.06k - $262.15k
...commitment to fairness, integrity, and global collaboration. This belief is... ...and implementing a global growth strategy for USP’s externally funded regulatory and laboratory programs. The incumbent... .... Supervisory Responsibilities Director / Sr Manager, International...Full timeWork experience placementWorldwide- The U.S. Pharmacopeial Convention (USP) is seeking a Senior Director, Global Programs (Regulatory and Laboratory) to lead a global growth strategy for externally funded regulatory and laboratory programs. The role focuses on building long-term relationships with funders...
$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine... ..., timely, and robust strategies for registration enabled by engagement with global health authorities. We... ...:Report to Executive Director or Associate Vice... ...of global regulatory submissions and approvals, including...Full timeFor contractorsLocal areaWorldwideFlexible hours- USP is seeking a Senior Director for Global Manufacturing Programs in Rockville, MD. This role requires a strategic leader to guide global health... ...teams, manage risks, and contribute to the organization's strategy while liaising with external partners. Candidates should...Full time
- Zenith LifeScience is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership... ...product portfolio. The RAD will serve as global regulatory lead on select programs and align regulatory strategy with clinical development and health...
$157.5k - $262.5k
...Applicant Portal:## Job Details: Director of Regulatory Affairs,Tactical and Implementation... ...project assignments with the Global Regulatory Leads and VP of Regulatory... ...implementation of regulatory strategies, IND development/submission/maintenance/tracking, BLA/sBLA planning...Worldwide- ...AstraZeneca’s Oncology Business Unit (OBU) in a role where strategy meets scientific ambition. As an Associate Director, OBU Strategy, you will assist in the creation and... ...success in the role.The role may require moderate global travel (Medical congress, Advisory boards and key...Hourly payFull timeTemporary workFlexible hours
- ...commercial expertise. You will integrate research strategies, design robust studies, and oversee global development from early research through... ...includes coordinating CROs, steering committees, regulatory submissions, and cross-border collaboration to ensure product...
- USP in Rockville, MD seeks a strategic leader to develop and implement a global growth strategy for externally funded regulatory and laboratory programs. You will build long-term relationships with funders and partners to expand programs in the U.S. and internationally...Worldwide
- USP, the U.S. Pharmacopeial Convention, seeks a Senior Director, Global Programs (Regulatory and Laboratory) to lead growth across regulatory and laboratory programming. You will develop strategic partnerships and oversee a global team, shaping opportunities in the United...
- ...seeks a senior leader to define AI design, governance and inspection readiness within GxP across a global manufacturing and quality network. You will translate strategy into standards, align the network on one way of working and enable speed and innovation. Reporting into...
- ...and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on... ...knowledge and application of global regulations governing... ...implementation of regulatory strategies for specific drug... ...planning, preparation and submission process for IND and licensing...Work at office
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