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
- ...Regulatory Affairs Manager / Senior Manager Gaithersburg, MD | Hybrid, onsite Tuesday through Thursday Green... ...technical, 100% hands on CMC regulatory role... ...coordinate CMC regulatory submissions and eCTD documentation... ...international teams, and global CMOs/CROs....SeniorFull timeSummer work
$186.23k - $279.35k
...Job Title: Global Regulatory Affairs Director Location: Gaithersburg... ...and life cycle management of the assigned... ...skill group such as CMC, Regulatory affairs project... ...and effective submissions, approvals and other... ...astrazeneca.com . #LI-Hybrid Date Posted...SuggestedHourly payTemporary workWork at officeLocal areaWorldwide3 days per week- ...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
- ...Role Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development... ...lead IND, BLA, sBLA submissions develop regulatory... ...and commercialization manage health authority interactions... ...trial labeling and CMC submissions...Senior
$218.06k - $327.09k
...you ready to set the global regulatory vision for pioneering... ...current stage through BLA submission, ensuring an... ...objectives with clinical, CMC, safety and... ...offs and mitigations to senior leadership to enable... ...Delivery and Milestone Management: Oversee all regulatory...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...Job Description Job Description The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance... ...that content, quality, accuracy, and format of submissions comply with applicable internal policies procedures as...Senior
- ...work together across global boundaries to make... ...the globe. As a Senior RegulatoryAffairs... ...of the global regulatory strategy for a product... ...markets, RA CMC as well as delivery... ...and update senior management on project risks/mitigation... ...from planning to submission of regulatory...SeniorHourly payTemporary workFlexible hours
$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- AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid... ...the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/ARAD staff across...Senior
- USP, based in Rockville, MD, seeks a Senior Strategic Programs Manager within the International Government & Regulatory Affairs team to drive strategic initiatives and manage... ...and provide strategic support to the EVP of Global External Affairs, advancing global access to...Senior
$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- Role: The Director of Regulatory CMC for Cell Therapy oversees management of multiple development and... ...and communicating global regulatory strategies, preparing... ...and reviewing CMC submissions, ensuring compliance, and... ...and is based on-site or hybrid. #J-18808-Ljbffr Bristol...
$186.23k - $279.35k
...AstraZeneca seeks a Global Regulatory Affairs Director in Gaithersburg to... ...commercialization, and lifecycle management. The role includes managing... ...skill groups including CMC and project management, overseeing... ...global regulatory submissions Requirements ~ Bachelor...$186.23k - $279.35k
...Are you ready to steer global CMC strategy for cell and gene therapies... ...programs, where your regulatory leadership translates pioneering... ...pioneering science into high-quality submissions and decisive health... ...Regulatory Intelligence and Risk Management: Interpret global...Hourly payTemporary work3 days per week- ...Senior Director leading global regulatory digital transformation strategy at AstraZeneca. Accountable for developing and implementing digital and data... ...strategies aligned with regulatory business priorities, managing cross-functional teams, and establishing governance...Senior
$212.99k - $319.44k
...Job Title: Senior Director Global Regulatory, Digital Location: Gaithersburg At AstraZeneca, we put patients first and strive to meet their... ...Regulatory Technology Governance Council (RTGC) and Regulatory Management Board (RMB). The Senior Director, Global Regulatory...SeniorHourly payTemporary workWork at officeWorldwide3 days per week$135.62k - $203.44k
...Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For over 30... ...every step. Role Overview:The Senior Manager, Regulatory Affairs US lead will be... ...management and execution of regulatory submissions in the US (e.g. INDs, BLAs/NDAs,...SeniorFull timeTemporary workWork at office- 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
- ...Senior Director leading global regulatory strategy for cell therapy programs across oncology, immunology, and... ...development from current stage through BLA submission, cross-functional product... ...-functional teams and stakeholder management ~ Strong strategic thinking, critical...Senior
$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- 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...
- ...Director, Regulatory CMC - Cell Therapy At Bristol Myers... ...for overseeing management of multiple development... ...strategic direction based on global regulatory guidelines... ...preparation of CMC submissions while ensuring... ...format to regulatory senior leadership team and other...Hourly payFull timeSummer workFlexible hoursShift work
$186.23k - $279.35k
...AstraZeneca seeks a Regulatory CMC Director to lead global chemistry, manufacturing, and controls strategy... ...oversight of regulatory pathways, dossier management, health authority engagement, and... ...Lead CMC components of regulatory submissions including INDs, IMPDs, BLAs, and...- ...AstraZeneca seeks a Senior Medical Director to lead clinical... ..., safety monitoring, and regulatory strategy within a global, cross-functional team environment... ..., and regulatory submissions Collaborate with investigators... ...governance approval and manage daily operations of...Senior
- The Senior Enterprise Policy Development Manager at U.S. Pharmacopeial Convention develops and manages evidence-based policy content to support Global External Affairs priorities and USP's mission to improve access to quality medicines. You will write policy statements...Senior
$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$200.18k - $286.16k
...fairness, integrity, and global collaboration. This... ...The Global GotoMarket Senior Director is responsible... ...scientific integrity, regulatory excellence, and... ...training in equitable management practices and tools to... ...order / back-to-back, or hybrid models). The role does...SeniorFull timeWork at officeLocal areaWorldwide- Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...clear regulatory strategies across global agencies. The leader will manage a team of regulatory strategists, direct global submissions (CTD), and align with business #J-1880...
- Senior Director, Global Pharmacovigilance (Safety Physician) Full details of the job. ImmunocoreSenior
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!
- compliance director Gaithersburg, MD
- compliance manager Gaithersburg, MD
- manager regulatory affairs Gaithersburg, MD
- director global regulatory affairs Gaithersburg, MD
- sr. manager regulatory compliance Gaithersburg, MD
- regulatory & compliance manager Gaithersburg, MD
- regulatory manager Gaithersburg, MD
- regulatory affairs director Gaithersburg, MD
- head compliance Gaithersburg, MD
- regulatory affairs manager pharmaceutical Gaithersburg, MD




