Senior Global CMC Regulatory Lead for Pharma Submissions
Pace® Analytical Services
Pace® Analytical Services in Maryland seeks an experienced CMC/regulatory affairs professional to lead regulatory submissions and strategies for client programs. You will author CMC sections, prepare Module 2/3 summaries, and interact with FDA, EMA, PMDA to keep products in compliance. A degree in biochemistry/related field with 10+ years of experience is preferred. This role offers a competitive hourly rate and a dynamic, mission-driven team environment. #J-18808-Ljbffr Pace® Analytical Services
- Pace Analytical Services LLC is seeking a senior CMC/regulatory affairs leader to author and coordinate regulatory submissions (INDs, IMPDs, CTAs) and related CMC documents. You will liaise with global health authorities to ensure compliance and expedite clinical trial...SeniorRegulatory
- Pace Analytical Services, LLC is seeking a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new and marketed products. You will prepare regulatory submissions, author CMC sections, and manage responses to authorities...Regulatory
- Emergent BioSolutions, Inc. is seeking a Senior Counsel - Commercial to join our dynamic Legal team. The role focuses... ..., strategic legal guidance across the US and global commercial landscape, including regulatory, privacy, and fraud & abuse matters, with emphasis on...SeniorRegulatoryFixed term contract
- Manufacturing & Tech Ops - Senior Manager Location(s... ...the support of a global service network... ...responsible for leading teams and... ...scope, and aligned to regulatory commitments. Coordinate... ...engineering, pharma cGMP facility start... ...Familiarity with regulatory submission processes (IND,...SeniorRegulatoryFull timeWork experience placementRemote workWork visa
- Position Summary The Senior FM Certification Lead is a senior-level subject matter expert responsible... ...ensure compliance with statutory and regulatory requirements while advancing... ...Competency (C2C) mapping and alignment submissions to OUSD(C). Provide executive-level...SeniorRegulatory
- Emergent BioSolutions, Inc. is seeking a Senior Counsel - Commercial to join its growing... ...commercial organization, focusing on regulatory risks including FTC guidance, anti-kickback... ...help drive compliant growth in US and global markets. #J-18808-Ljbffr Emergent BioSolutions...SeniorRegulatoryFixed term contract
- Navitas Life Sciences Pvt. Ltd. seeks an Associate Director - Regulatory Publishing to lead end-to-end publishing for IND/NDA/MAA/BLA filings across multiple regions, ensuring timely eCTD submissions and lifecycle maintenance. The role requires strong project management...Regulatory
- Trustpoint.One is seeking a temporary Lead Counsel to partner with a material sciences company, providing... ...-to-end legal leadership on commercial, IP, and regulatory matters. The successful candidate will support four global business units, drive strategic guidance, and...RegulatoryTemporary work
$85 per hour
...health and safety of our communities and lives. Lead and execute global regulatory strategies to ensure our client’s investigational... ...$85.00 per hour Key Responsibilities Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs...SeniorRegulatoryRemote jobHourly payFull timeReliefLocal areaImmediate startMonday to FridayFlexible hoursShift work- ...and process licenses issued by the Commissioner. The position may involve leading Licensing Specialists and Analysts, with responsibilities for reviewing non-depository licenses and other regulatory matters and ensuring compliance with state law. The role emphasizes...SeniorRegulatoryRemote jobWork at office
- ...inVentiv Health Commercial LLC is seeking a Sr Medical Writer to lead the completion of medical writing deliverables. This role... ...activities for individual studies, ensuring clarity and adherence to regulatory standards, and mentoring less experienced writers. The ideal...SeniorRegulatoryRemote jobFlexible hours
$167.5k - $282.33k
The Opportunity: The Senior Director, Global Engineering provides strategic and operational leadership... ..., commissioning, and handover. Lead front-end engineering design, and execution... ...engineering designs meet or exceed all regulatory and corporate safety standards. Embed...SeniorRegulatoryFor contractorsLocal areaRemote work- Annapolis Micro Systems, Inc. is seeking a Senior Program Manager to own and drive customer programs from concept through fulfillment. You will coordinate with Engineering, Sales, and Management to ensure clear requirements and timely delivery, while maintaining strong...Senior
- ...Company, Inc. is seeking an ESG Controller to lead governance, controls, and disclosure... ..., ensuring readiness for evolving global regulatory requirements. The role partners with Sustainability... .... The position reports to the Senior Director, External Reporting and focuses...Regulatory
- Pandora is hiring a Senior Manager, EHS & Facilities for the Americas Omni Operations. Lead EHS, Sustainability, Facilities, Security... ...Center. Drive safety, regulatory compliance, and continuous improvement... ...Procurement, Technology, and Global teams to elevate workplace safety...SeniorRegulatory
- SOLV Energy is looking for a Senior HV Project Manager to oversee utility-scale substation and transmission projects. You will ensure project execution adheres to safety and regulatory standards, involving extensive coordination. This remote role requires a minimum of 5...SeniorRegulatoryRemote job
$100k - $130k
...with the support of a global service network and distribution... ...services. Job Title Senior Corporate Paralegal (... ...including the leading OneSource Field and Laboratory... .... Compliance & Regulatory Filings Monitor... ...other compliance-related submissions. Cross-Functional Collaboration...SeniorRegulatoryRemote jobFull timeContract workWork at officeLocal area$97k - $193k
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents... ...you’ll receive extensive support through regulatory submissions, TMF management, and in‑house CRAs for... ...clear career path and development that can lead to Clinical Trial Manager roles. We...SeniorRegulatoryRemote jobHourly payWork at officeWorldwide$115k - $120k
...Position Summary The Senior Quality Engineer leads the quality strategy for complex... .... Working in an Agile, globally dispersed team, this role... ...complying with security, privacy, regulatory, and Responsible AI... ...steps, including submission of a government issued photo...SeniorRegulatoryFull timeImmediate startWork from home- ...laws and regulations while managing legal risks in a global context. The role requires leading cross-functional collaborations with commercial, sales... ...EHS, and supply chain teams, and working with global legal teams on complex regulatory matters. #J-18808-Ljbffr ABB Inc.SeniorRegulatoryRemote job
$74.1k - $148.3k
...exciting time to join us! As a global leader we're looking for a Senior Lead Clinical Research Associate (CRA)... ...specialists for legal matters. Ensure regulatory compliance: Coordinate with... ...and support the preparation and submission of essential site documents....RegulatoryFull timeContract workTemporary workFlexible hours$118.4k - $196.8k
...RESPONSIBILITIESFormulary & Utilization Management Strategy & Development: May lead Highmark’s evidence-based medicine drug evaluation program... ...of member specific information to improve individual outcomes.Regulatory Compliance & Oversight: Execute Highmark’s Pharmacy &...SeniorRegulatoryFull timeFor contractorsWork at officeLocal areaRemote workWork from home- Kiva is seeking a Senior Manager, Public Relations to lead PR, media strategy, and partner campaigns globally from a remote U.S. work setup. The role drives thought leadership, analytics, and channel amplification, partnering with Marketing and Strategic Partnerships to...SeniorRemote jobPermanent employment
$134.1k - $214.5k
...for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating... ...Global MDx Marketing Director, this role leads global marketing initiatives for the... ...incorporating local clinical practices, regulatory considerations, and customer needs. Why...SeniorRegulatoryHourly payLocal areaWorldwideShift work- Salesforce seeks a Health & Life Sciences Program Manager—an executive-facing IC role within Global Life Sciences Acceleration Hub. This senior professional advises top executives across complex customer engagements, shaping governance, risk, and program delivery for enterprise...Senior
$134.1k - $214.5k
...for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating... ...Strategy and Global Commercialization Lead the global marketing strategy for the... ...across Product Management, R&D, Regulatory, Medical and Scientific Affairs, Regional...SeniorRegulatoryHourly payWork at officeLocal areaRemote workWorldwideShift work- Gore is seeking an experienced Legal Counsel to support four global businesses including Clean Energy, PharmBIO, ELIXIR Strings, and... ...with Gore legal colleagues on IP, employment, compliance, and regulatory matters. The position is based in Elk Mills 2 and Appleton East...RegulatoryWork at office
- McCormick & Company is seeking a Global Sustainability Director, Climate Strategy & Transition to lead the enterprise climate program from its Global Headquarters in... ...and guide external partnerships and reporting to meet evolving regulatory #J-18808-Ljbffr Trellis GroupRegulatory
- A nonprofit organization is seeking an Executive Assistant to provide top-level assistance for high-level executives in Baltimore County. The ideal candidate will manage complex scheduling across multiple time zones, coordinate meetings, and handle travel arrangements. ...Senior
- ...the United States is hiring an Employee Relations Specialist (Senior IC) to lead complex ER investigations and advise on performance, policy,... ...and proactive risk mitigation, with remote/hybrid work options and collaboration across global teams. #J-18808-Ljbffr RelativitySeniorRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Global CMC Regulatory Lead for Pharma Submissions. Be the first to apply!
- senior living Annapolis, MD
- senior associate vice president Annapolis, MD
- senior app developer Annapolis, MD
- senior ml engineer Annapolis, MD
- senior application support engineer Annapolis, MD
- senior manager data analytics Annapolis, MD
- senior devops Annapolis, MD
- senior property accountant Annapolis, MD
- senior IT manager Annapolis, MD
- sr operations manager Annapolis, MD



