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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Director, Global Regulatory Strategy & Submissions in Gaithersburg, MD vacancy
- 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
$186.23k - $279.35k
...Job Title : Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...to role: Are you ready to steer global regulatory strategy for cell therapies... ...interactions through major submissions and post-approval maintenance—helping...SuggestedHourly payTemporary workWork at officeLocal areaFlexible hours3 days per weekGaithersburg, MD21 days ago- 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
...Job Title: Global Regulatory Affairs Director Location: Gaithersburg At AstraZeneca, we put patients... ...future regulatory requirements and strategies. Influences Regulatory authorities... ...interface enabling rapid and effective submissions, approvals and other product...SuggestedHourly payTemporary workWork at officeLocal areaWorldwide3 days per weekGaithersburg, MD5 days ago$218.06k - $327.09k
...Are you ready to set the global regulatory vision for pioneering cell... ...labeling. You will shape strategy for complex, visible programs... ...will report to the Executive Director, Cell Therapy Regulatory... ...current stage through BLA submission, ensuring an efficient route...Hourly payTemporary workStart working todayWork at officeFlexible hours3 days per week$155.52k - $233.28k
...ll have the platform (and sponsorship) to make it real. About Global Patient Solutions Within Global Patient Solutions, you will translate... ..., you will help evolve and scale our global patient engagement strategy, includingcomplex patient solutions andConnect360, by...Hourly payTemporary workWork at officeWorldwideFlexible hours3 days per week- ...Job Description The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing... ...promotional material and labeling strategy and activities for assigned products... ...content, quality, accuracy, and format of submissions comply with applicable internal...
Precigen, Inc
Germantown, MD10 days ago - ...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 payContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- 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...
$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 officeWorldwideUS Pharmacopeia
Rockville, MDa month ago$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 areaWorldwideQiagen
Germantown, MDa month ago- MaxCyte, Inc. seeks a Director of Global Marketing to develop and execute a global strategy that drives commercial growth, strengthens our brand, and fuels qualified demand across our cell engineering platform, products, and services. The role partners with Sales, Product...
$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 areaGSK
Rockville, MDa month ago- 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
- GSK in the United States is seeking a senior Regulatory Affairs leader to develop and execute regional/global regulatory strategies for assigned assets. The role collaborates with GRL, MDT/EDT, and local/regional teams to secure optimal labeling and timely approvals. The...Local area
$129k - $203.1k
...Job Description The Regulatory Intelligence Lead monitors and analyzes global regulatory, scientific, and policy developments... ...questions - and regulatory strategy. - Leverage a combination of... ...development of company messaging for submission through - appropriate channels -...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workMerck & Co.
Rockville, MD11 days ago$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- ...Job Description Job Description Senior Director, Global Product Strategy Who We Are Association for Financial Professionals (AFP) drives the future of finance and treasury by developing the leaders of tomorrow through world-class certifications, learning experiences...Casual workLocal areaFlexible hours
Association for Financial Professionals
Bethesda, MD18 days ago $270.22k - $405.33k
...types, we rely on highly skilled Strategy Leads to craft integrated... ...platforms. -- As an Executive Director, Strategy, Oncology R&D, you will own and drive the global Oncology R&D strategy, setting... ...design, competitive dynamics, regulatory environments, and market...Temporary workWork at officeRemote workFlexible hours3 days per weekGaithersburg, MD19 days ago- AstraZeneca GmbH is seeking a regulatory leader in Gaithersburg, MD, to oversee the global CMC strategy for cell and gene therapies. You will ensure the delivery of high-quality submissions and navigate complex health authority interactions. The ideal candidate will possess...
- AstraZeneca is seeking an Executive Director, Strategy, Oncology R&D to own the global oncology strategy and portfolio choices. You will interact with senior leaders to shape priorities, invest in high-impact assets, and drive evidence-based decisions across clinical,...
$267.91k - $401.87k
...impact at AstraZeneca by leading strategy for our industry-leading... ...eradicating cancer. As Executive Director, Oncology Business Unit (OBU)... ...with Oncology R&D and global franchise partners. Engage... ...Thorough understanding of regulatory and pricing dynamics in major...Temporary workWork at officeRemote workFlexible hours3 days per weekGaithersburg, MD20 days ago- ...enterprise leader to spearhead AI initiatives from their Gaithersburg office. This role involves developing an AI/digital acceleration strategy, influencing cross-functional teams, and ensuring responsible AI deployment across medical practices. The ideal candidate...Work at office
$178.53k - $267.8k
Regulatory Affairs Director - Oncology Location: USA - Gaithersburg MD Would you... ...your Regulatory Affairs strategy expertise and passion to make... ...products. Serves as the global regulatory lead (GRL) on... ...teams in major regulatory submissions (NDA/BLA/IND/CTA), health...Hourly payTemporary work3 days per week- AstraZeneca in Gaithersburg, MD, seeks a Director Regulatory Intelligence (RID) to translate emerging regulatory signals into choices for pipeline... ...’ll join a diverse team to deliver capabilities supporting strategy and portfolio decisions. You will partner with senior...
$193.9k - $290.85k
...patients around the world. The Director of Hematology Ambition & Disease Strategy will be a part of the US Hematology Key... ...regional marketing, medical affairs, regulatory, corporate affairs, patient advocacy, field sales, global franchise, research & development and...Temporary workRemote workGaithersburg, MD12 days ago- ...Job Description The Manager, Regulatory Writing, is responsible for... ...to regulatory messaging strategy and overseeing the regulatory... ...assigned programs to support submissions and business objectives. Reporting... ...~ Strong understanding of global regulatory requirements....
Precigen, Inc
Germantown, MD10 days ago - ...PharmaceuticalsSelling Points Lead impactful regulatory projects at a dynamic organization with global reach. Collaborate across... ...regulatory strategy development and implementation... ...manage scientific and regulatory submissions, including INDs, NDAs/BLAs, IMPDs...
Green Key Resources
Gaithersburg, MD7 days ago $186.23k - $279.35k
...Are you ready to transform Regulatory Intelligence into actionable... ...as a Regulatory Intelligence Director. This role sits at the intersection... ...science, and portfolio strategy translating emerging signals... ...group of individuals including global regulatory strategists, medical...Hourly payTemporary workWork at officeFlexible hoursShift work3 days per weekGaithersburg, MDa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Global Regulatory Strategy & Submissions. Be the first to apply!
Related searches
- director global regulatory affairs Gaithersburg, MD
- compliance manager Gaithersburg, MD
- manager regulatory affairs Gaithersburg, MD
- regulatory affairs manager pharmaceutical Gaithersburg, MD
- regulatory manager Gaithersburg, MD
- compliance director Gaithersburg, MD
- regulatory affairs director Gaithersburg, MD
- head compliance Gaithersburg, MD
- regulatory & compliance manager Gaithersburg, MD
- planning director Gaithersburg, MD