Regulatory Program Manager - Global Submissions Leader
Medasource
Eight Eleven Group is seeking a Regulatory Program Manager to lead operational execution of regulatory strategy for its Oncology portfolio. The RPM will translate global regulatory plans into executable actions and coordinate cross-functional teams to ensure timely, high-quality submissions. The role requires deep experience in global regulatory affairs, project management, and the ability to influence without formal authority. #J-18808-Ljbffr
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Program Manager - Global Submissions Leader in Spring House, PA vacancy
- ...2 month rolling contract The Regulatory Program Manager (RPM) will be an asset-level operational leader, driving projects forward through... ...and distillation of overall global regulatory strategy to... ...and/or management of worldwide submissions, driving processes to optimize...SuggestedContract workLocal areaWorldwideFlexible hours3 days per week
$164k - $282.9k
...merit. Job Function Regulatory Affairs Group Job... ...Category People Leader All Job Posting... ...and executes robust global and North American... ...key regulatory submissions; and leads and supports... ...-related issues. Manage routine... ...long-term incentive program. Benefits Vacation...SuggestedLocal areaImmediate startRemote work$117k - $201.25k
...recognize their merit. Job Function Regulatory Affairs Group Job Sub Function... ...applications will be considered as a single submission. About Innovative Medicine Our... ...for the best talent for our Manager, Global Labeling Product Leader to be based in Raritan, NJ; Titusville...SuggestedLocal areaImmediate startWorldwideJohnson & Johnson
Horsham, PA2 days ago- CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets. You will coordinate with Regulatory, Project...Suggested
- ...Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to lead global regulatory strategy for ophthalmology programs, with oversight of retinal disease... ...experience, including NDA/BLA submissions, and a proven track record of delivering...Suggested
- Senior Manager, Regulatory Submission Locations: King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UK Work Arrangement: Hybrid - 3 days onsite Reports to: Global Submission Management Lead CSL's R&D organization is accelerating innovation to deliver greater impact...Local area
- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for... ...closely with cross-functional leaders in Global Regulatory Affairs CMC, Global... ...functions.Manage the development and submission of high-quality, compliant CMC regulatory...Full timeLocal areaFlexible hours
CSL
Valley Forge, Montgomery County, PA5 days ago - ...requires the role to manage and deliver tactical... ....Serve as the Program Manager for all Global Security programs and... ...enforcement and other regulatory agencies· As needed,... ...governance cadences, submission and aggregation of reports... ...biotherapeutics leader driven by our...Full timeTemporary workLocal area
CSL
King of Prussia, PA7 days ago - ...Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational... ...market registrations, and post-approval submissions for biopharmaceutical products. Based in... ...content, and represent the company in global health authority meetings, #J-18808-...
Madrigal Pharmaceuticals Inc
Conshohocken, PA3 days ago - ...Director and Head of GDMS Process & Quality Management to lead development, implementation, and... ...activities. Reporting to the Head of Global Data Management and Standards, this role... .... The role partners with clinical programs, trial teams, and quality/compliance groups...
Regulatory Jobs
North Wales, PA4 days ago - ...Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within IDAR to provide expert guidance on clinical data submission requirements... ...point of contact for data management, statistical programming, and global regulatory affairs, ensuring SDTM/ADaM readiness...
6084-Janssen Research & Development, LLC Legal Entity
Spring House, PA3 days ago - ...Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New... ...scientific strategy and global CMC approaches. You will lead... ...regulatory activities, prepare submissions, and ensure compliance with... ...while supporting lifecycle management and inspections. #J-18808-Ljbffr...
Johnson & Johnson Innovative Medicine
Horsham, PA4 days ago - ...Regulatory Affairs ManagerIntegrated Resources... ...solutions that help you manage your talent and... ...:The Regulatory Program Manager (RPM) will... ...business support to Global Regulatory Affairs... ...the Regulatory Leader (GRL) to proactively... ...interactions and submissions.Works in close collaboration...Temporary workWorldwide
Careers Integrated Resources Inc
Spring House, PA4 days ago - ...Merck & Co. in the USA seeks the Head, Site Budgets to lead the global site budgeting capability and the Trial Initiation Specialist... ...budget strategy, drive performance, and ensure governance and regulatory alignment across regions and countries. You will partner with regional...
Merck & Co. Inc
North Wales, PA2 days ago $129k - $203.1k
...manufacturing sites and commercial teams to manage supply and demand issues for their... ...operations and functional leads, Value Chain leaders, VCM Product leaders and Centers of Excellence... ...Team to integrate Regional and Global Brand Strategies into supply plans within...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA4 days ago$164k - $282.9k
...Director-level regulatory affairs leader responsible for developing and executing... ...regulatory strategies, managing cross-functional teams, and... ...priorities, leads regulatory submissions, and drives compliance across... ...and timelines for global regulatory dossiers including...- ...a variable cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product Leader for the Infectious Diseases/Vaccines/Global Public... ...components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate)...Work at officeImmediate startFlexible hours
Artech
Spring House, PA5 days ago - ...The role requires strong team leadership, brand and launch strategy expertise, and cross-functional collaboration. You will guide global launch planning, forecast development, and cross-market alignment with regional partners, ensuring differentiated messaging and value...
- Johnson & Johnson is seeking a Global Process Owner (GPO), Product Quality Reporting, for... ...Quality, to lead BPDR/FAR and APR/PQR programs across Titusville, NJ; Raritan, NJ; or Horsham... .... The GPO will partner with sites, Regulatory, MSAT and platform teams to deliver...
- Merck is seeking an Associate Director/Direct Global Supply Chain Management Business Processes to lead key SCM and manufacturing operation processes... ...making. You will collaborate with E2E planners, product leaders, GLP planners and finance teams, while expanding IT...
$173.2k - $272.6k
...The Clinical and Regulatory Strategic Communications... ...department within Global Clinical Trial... ...across multiple programs and therapeutic areas... ...writers. May manage direct reports including... ..., key clinical submission documents) and/or... ...global health care leader with a diversified...For contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift workMSD
North Wales, PA1 day ago$115.4k - $192.3k
...Our work transforms complex patent submissions into standardized, searchable... ...the Role We are seeking a Senior Program Manager to support strategic modernization... ...Legal & Professional is a leading global provider of legal, regulatory and business information and analytics...Work at officeLocal areaLexisNexis Legal & Professional group
Horsham, PA4 days ago$129k - $153k
...difference worldwide.Position Overview: Regulatory leaders who leverage regional regulatory... ...an innovative, scientifically sound, global, integrated regulatory vision/strategies... ...for Module 1 documentation required for submission and supports response to health authority...Full timeWorldwideRelocation packageCSL
King of Prussia, PA5 days ago- Merck in Rahway, NJ or Upper Gwynedd, PA seeks an Associate Director, Global Oncology Marketing to lead launch planning for priority Oncology products. You will drive readiness, coordinate across brand teams and functions, and implement the Launch Excellence Framework...
- ...Johnson & Johnson seeks a Manager, Global Labeling Product Leader to oversee strategic development and lifecycle management of product labeling across... ..., coordinating global labeling strategy, and ensuring regulatory compliance and scientific integrity....Worldwide
Johnson & Johnson
Horsham, PA3 days ago - Merck & Co. is seeking a Director of Global Respiratory Finance to partner with the SVP Global Marketing, delivering accurate revenue... ...activities, influence brand strategy through launches and lifecycle management, and collaborate with manufacturing and commercial teams to...
- Merck in USA/PA seeks a Director, Global Respiratory to advise on revenue forecasts, resource investments, and key metrics for the SVP Global Marketing. The role ensures timely and well-vetted forecasts and supports strategic decisions across the Global Respiratory portfolio...
- Role Lead the global Regulatory Data Office within Johnson & Johnson's Innovative Medicine R&D, focusing on data governance, stewardship, and... ...with global regulatory requirements (e.g., IDMP, xEVMPD) manage day-to-day operations of the Regulatory Data Hub support RIM...Work at office
$210.4k - $331.1k
...accomplished scientific leader to join the... ...is part of the Global Clinical Development... ...for oncology programs from post-preclinical... ...development and regulatory decisions.This... ...including performance management, hiring,... ...modules, NDA/BLA submissions)Ensure delivery of...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
North Wales, PA6 days ago$102.9k - $153.1k
...States, we are a pioneering global organization offering an always... ...Global Trade Compliance Manager is responsible for managing key... ...Company's global trade compliance program, ensuring compliance with U.S... ...duty savings, and support regulatory compliance initiatives across...Full timeWork at office1 day per weekDorman Products
Colmar, PA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Program Manager - Global Submissions Leader. Be the first to apply!
Related searches
- quality control team lead Spring House, PA
- IT team lead Spring House, PA
- leader Spring House, PA
- merchandise team leader Spring House, PA
- team lead Spring House, PA
- helpdesk team lead Spring House, PA
- healthcare team leader Spring House, PA
- inventory team lead Spring House, PA
- school leader Spring House, PA
- clinical team leader Spring House, PA