Senior CMC Regulatory Manager - Hybrid, Global Submissions
Green Key Resources
Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in Gaithersburg, MD for a 100% hands-on CMC role. The position is hybrid with onsite Tue-Thu. You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master’s or PhD with extensive regulatory experience in commercial products and knowledge of FDA, Health Canada, and EMA requirements. #J-18808-Ljbffr Green Key Resources
- GlaxoSmithKline seeks an experienced Regulatory Affairs Manager (CMC) for mRNA vaccine development, located in the US across multiple... ...expertise, and the ability to manage complex submissions across US/EU markets within a hybrid work model. #J-18808-Ljbffr GlaxoSmithKlineSuggested
- Regulatory Affairs Manager / Senior Manager Gaithersburg, MD | Hybrid, onsite Tuesday through Thursday Green Key Resources... ..., 100% hands on CMC regulatory role... ...coordinate CMC regulatory submissions and eCTD documentation... ...international teams, and global CMOs/CROs....SeniorSummer work
$113.85k - $189.75k
...programme offers a remote or hybrid working model,... ...R&DRegulatory Affairs Manager, CMC mRNA Vx Development ProductsAs a Regulatory Affairs Manager in Chemistry... ...a meaningful impact on global health while advancing... ...documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA...SuggestedFull timeWork at officeLocal areaRemote work- ...work together across global boundaries to make... ...globe. As a Senior RegulatoryAffairs... ...implementation of the global regulatory strategy for a... ...markets, RA CMC as well as... ...and update senior management on project risks/mitigation... ...from planning to submission of regulatory...SeniorHourly payTemporary workFlexible hours
- ...motivated and experienced Senior Manager/Manager, Regulatory Affairs(level based on candidate... ...and application of global regulations governing pharmaceutical... ...of Precigen's quality, CMC, preclinical, and clinical... ...planning, preparation and submission process for IND and...SeniorWork at office
- The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and... ...Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies procedures as...Senior
$171.6k - $286k
...seeking an experienced regulatory leader to join our Global Regulatory Strategy... ..., regulatory submissions, milestone meetings... ...perspectives with senior leaders and health... ...registration and lifecycle management. Experience leading... ...and offers a hybrid working model. We encourage...Work at officeLocal areaRemote work- AstraZeneca plc in the United States seeks a Director of Promotional Regulatory Affairs to set the guardrails that allow bold yet compliant... ...demands leadership, deep FDA knowledge, and experience shaping global to US promotional materials while mentoring teams #J-18808-...Senior
- ...AstraZeneca plc is seeking a Senior Regulatory Affairs Director to oversee global regulatory strategy for... ..., guides regulatory submissions, and interacts with... ...approvals. Flexible hybrid work is available with... ...strategic decision-making, manages complex global dossiers...Flexible hours
$186.23k - $279.35k
...myGwork – the largest global platform for the LGBTQ+... ...ready to steer global CMC strategy for cell and... ...programs, where your regulatory leadership translates... ...science into high-quality submissions and decisive health... ...Intelligence and Risk Management: Interpret global regulations...Hourly payTemporary work3 days per week$171.75k - $286.25k
...Summary The Director, Global Regulatory Strategy- Oncology is... ...includes people leadership, manage and develop direct or... ...teams. Partner with senior stakeholders to... ...You? Work arrangement: Hybrid, with regular presence... ...Commercial, Statistics, CMC, and other R&D functions...Work at officeLocal area2 days per week3 days per week$208.06k - $262.15k
...to fairness, integrity, and global collaboration. This belief is... ...prioritizes scientific integrity, regulatory excellence, and evidence-... ...includes training in equitable management practices and tools to... ...regulatory and laboratory programs Senior Pharmacovigilance...SeniorFull timeWork experience placementWork at officeWorldwide- ...Oxford, UK Department Regulatory Affair s Key Responsibilitie... ..., IND development/submission /maintenance, BLA/sBLA... ...involve interacting with our global sites, both in-house... ...submissions. You will manage, prepare, co-ordinate and... ...trial labelling and CMC submissions for regulatory...Full timeWork at officeLocal areaWorldwideNight shift
$250k - $300k
...roots to our current global presence, we've... ...opportunity This is a senior global leadership role in Regulatory Affairs responsible... ...pre-market submissions, post-market surveillance... ...business objectives.Manage the annual Global Regulatory... ...Assistance Program Hybrid work (conditional...Full timeLocal areaWorldwide- ...Accountabilities Oversee regulatory project management and operational delivery... ...approved products across the global Infectious Disease... ...and implement regulatory submission models that improve efficiency... ...the ability to influence senior internal stakeholders in complex...SeniorHourly payTemporary workLocal area3 days per week
$200.81k - $286.16k
...play a vital role in increasing global access to high-quality... ...prioritizes scientific integrity, regulatory excellence, and evidence-... ...includes training in equitable management practices and tools to promote... ...driven work environments.The Senior Technical Director, Global Manufacturing...SeniorFull timeWork at officeWorldwide- ...is seeking a Director of Regulatory Affairs Strategy for cell... ...The role focuses on shaping global regulatory strategy for CGT... ...teams, partner with senior leaders, and manage Health Authority interactions... ...expedited designations to major submissions, ensuring patient value...
$166.65k - $277.75k
...Regulatory DirectorEnsure the development of appropriate... ...of an overall global regulatory approach and... ...product life.Advocate to senior leaders in GSK and in... ...regional development, submission and approval activities... ...pace, rigour and risk.Managing individual and team performance...Temporary workLocal area- GSK seeks an experienced Director of Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets... ..., coordinate with global teams and drive regulatory submissions with health authorities throughout the lifecycle. You will lead...
- ...REGENXBIO Inc. in Rockville, MD, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategy from early development through... ...forward and coordinating across functions. You will drive submission activities, prepare FDA/EMA documentation, and guide...Senior
$119.97k - $141.09k
...Your Role The Sr. Manager, Trade Compliance & Logistics is a strategic... ...adherence to U.S. and global trade regulations while optimizing... ...to the United States. Drive regulatory/operational oversight:... ...customs administrative entry submission as appropriate with support of...SeniorWork at officeLocal area- ...Global Alliant, Inc. is seeking a Salesforce Architect for Rockville, MD. This full-time role offers hybrid/remote options and requires US citizenship. The architect will design end-to-end Salesforce solutions aligned with business goals and ensure scalable architecture...SeniorFull timeRemote work
- ...seeks a highly motivated Client Account Sr Manager to strengthen DHS partnerships. You will be the primary contact for regional and global accounts, developing, growing and... ...teams to deliver solutions on time. This hybrid role can be based in Arlington, VA; Baltimore...SeniorRemote work
- Immunocore is seeking a Director of Regulatory Affairs to lead the Tactical... ...team, overseeing US and EU submissions, IND/CTA planning, and regulatory intelligence across global programs. This role drives... ...with health authorities, manage resources, and ensure compliance...Worldwide
- Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling and promotion strategy, ensuring compliance across... ...teams to deliver compliant material and submissions. The role requires deep regulatory expertise, strategic...
$126.25k - $171.58k
...is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core... ...collaborative work environment.Brief Job Overview The Senior International Regulatory Affairs Manager serves as a critical enabler of regulatory engagement...SeniorFull timeWork at officeWorldwide$138.6k - $231k
...are seeking a talented Regulatory Affairs professional... ...& Inflammation (RII) Global Regulatory Strategy team... ...RII). Job purpose: The Manager / Associate Director... ...regulatory interactions, submissions, and review processes.... ...: This role is hybrid. Regular on-site collaboration...Full timeLocal area2 days per week3 days per week- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure...Remote job
- Sikich in Rockville, MD is seeking a Senior Tax Manager for a hybrid role. You will lead complex tax engagements, review returns, provide planning strategies, and collaborate with partners and clients to drive compliant, opportunistic tax solutions. Applicants should have...Senior
$218.06k - $327.09k
...played an important role as part of a truly global effort to respond to a new and... ...reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the... ...etc.). Proven leadership and program management experience, as well as the ability to think...SeniorHourly payTemporary workWork at officeFlexible hours3 days per week
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