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
- AstraZeneca plc seeks a Director of Regulatory Affairs CMC to steer global CMC strategy for cell and gene therapies, turning pioneering science into high-quality submissions and decisive health authority interactions that accelerate patient access. Based in Santa Monica...Suggested
$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- ...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
- 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
$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 payFull timeTemporary work3 days per week$171.6k - $286k
...myGwork - the largest global platform for the... ...an experienced regulatory leader to join... ...will operate as a senior individual contributor... ..., regulatory submissions, milestone... ...registration and lifecycle management. Experience... ...Belgium and offers a hybrid working model. We...Work at officeLocal areaRemote work$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... ...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$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- As Senior Director, Regulatory Affairs Management for the Infectious Disease Unit, you will lead and develop the Regulatory Affairs... ...partner with Regulatory Affairs colleagues globally to ensure high-quality, compliant submission delivery, strengthen organizational...SeniorHourly payFull timeTemporary workLocal area3 days per week
- ...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...
- 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...
- 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...SeniorFull timeLocal area
- ...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
- 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
- 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...
- 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
$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$90k - $110k
...Senior Account Manager Discover a career that empowers you - join HUB International... ...the resources of a global firm and the agility of a... ...Ellicott City, MD office on a Hybrid work schedule. The... ...and prepare applications for submission to the Marketing Department...SeniorInternshipWork at officeLocal areaFlexible hours$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- 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 global... ...meetings etc.). Proven leadership and program management experience, as well as the ability to...SeniorHourly payFull timeTemporary workWork at officeFlexible hours3 days per week$196.7k - $353.4k
...a Sr. Director of Regulatory Strategy to lead Regulatory... ...new drug modality globally. The Sr. Director... ...for regulatory submissions and related... ...data, organizes and manages participation in meetings... ...with RA CMC and verifies accuracy... ...Project Team and senior management, as relevant...SeniorPermanent employmentFull timeWork at officeWork from home$288.06k
Senior Global Development Medical DirectorAstraZeneca is seeking a Senior... ...the Global Clinical Head, regulatory agencies, external medical... ..., Phase IV, and life-cycle management studies.Essential... ...Experience with regulatory submissions, publications, congress presentations...SeniorFull timeTemporary workWork at officeWorldwide3 days per week- GlaxoSmithKline seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for oncology assets in alignment with development plans and evidence strategies. You will lead or contribute to Regulatory Matrix Team activities and interact...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CMC Regulatory Manager - Hybrid, Global Submissions. Be the first to apply!
- sr. manager regulatory compliance Gaithersburg, MD
- regulatory manager Gaithersburg, MD
- senior director regulatory affairs Gaithersburg, MD
- training and compliance manager Gaithersburg, MD
- regulatory affairs manager pharmaceutical Gaithersburg, MD
- regulatory affairs director Gaithersburg, MD
- senior regulatory manager Gaithersburg, MD
- manager regulatory affairs Gaithersburg, MD
- head compliance Gaithersburg, MD
- compliance director Gaithersburg, MD



