Global Regulatory Strategy & Submissions Lead
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine in Spring House, PA, is seeking a seasoned Regulatory Affairs professional to support global submissions and interactions with health authorities. The role covers IND/CTA/NDA/MAA processes, regulatory strategies, and cross-functional collaboration to ensure timely filings. You will contribute to NDA/MAA preparation, coordinate with LOCs, and help maintain timelines while staying compliant with FDA and ICH guidelines. Travel up to 10% may be required. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Strategy & Submissions Lead in Spring House, PA vacancy
- ...Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, to drive global regulatory strategies for large molecules, vaccines, and delivery devices. You will lead CMC submissions and align with GRA leadership across markets. The role...Regulatory
- ...Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead global regulatory strategies for large molecules and drive regulatory submissions across markets. The role partners with CMC teams to ensure lifecycle management...Regulatory
- ...Behring seeks an Associate Director, Regulatory Project Manager to lead global regulatory planning and execution... ...three days weekly, coordinating submissions and cross-functional teams for timely... ...with policy to align regulatory strategy and execution. #J-18808-Ljbffr...Regulatory
- CSL Behring is seeking a Regulatory Leader to drive regional regulatory strategies for assigned products, aligning with the Global Regulatory Affairs Strategy Team and regional health authorities. This role emphasizes collaboration, risk-taking, and timely regulatory outcomes...RegulatoryRelocation
$117k - $201.25k
...their merit.Job Function: Regulatory Affairs GroupJob Sub... ...as a single submission.Johnson & Johnson Innovative... ...recruiting for a Manager, Global Labeling Product... ...responsible for the following:Lead the development,... ...in the global labeling strategy, including demonstrating...RegulatoryFull timeLocal areaImmediate startWorldwide- Johnson & Johnson Horsham site seeks a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. You will develop global CMC strategies, lead regulatory dossiers, and provide direction on large molecule programs across markets. Responsibilities include leading...Regulatory
$119.77k - $140.9k
...Day One.Job DescriptionSUMMARYThe Digital Collections Email Strategy Lead is responsible for the design, execution, and continuous optimization... ...of applicable laws, regulations, financial services, and regulatory trends that impact default management.- Strong presentation,...RegulatoryFull timeWork experience placementLocal area$253k - $309k
...connected by our shared purpose: leading the fight against MASH.... ...strengthening our workforce strategy to ensure we have the right talent... ...way.The Senior Director, Global Publications Lead is responsible... ..., compliance, legal, and regulatory affairs to ensure consistent...RegulatoryFull timeFreelanceWork at officeLocal areaFlexible hoursNight shift3 days per week- ...oversee a divisional compliance team, ensuring regulatory alignment across its technology landscape. You will lead IT compliance strategy for large-scale capital investments and... ...and business units, ensuring operations meet global standards. You will manage a high-...Regulatory
- Ecolab is seeking a Biopharma Regulatory Strategist to shape and execute regulatory strategies that accelerate growth across Life Sciences and Bioprocessing. You will partner with Regulatory, Commercial, R&D, Digital, Government Relations, and key account teams to position...Regulatory
- Merck & Co., Inc. seeks an Associate Director of HCP Strategy for HIV Daily Treatments to lead development of strategy and assets for a high-visibility... ...You will partner with analytics, market research, and regulatory partners to inform data-driven decisions and drive...RegulatoryDaily paid
- ...Innovative Medicine is seeking a Manager, Regulatory Medical Writing to support across key... ...and potential remote options. You will lead preparation of clinical documents, guide... ...and ensure regulatory compliance across submissions. Strong leadership, writing, and project...RegulatoryRemote work
- CSL Plasma Inc. is seeking a Head of Global Regulatory Affairs CMC to oversee regulatory strategy and operations. This role is critical in developing regulatory CMC... ...in biological sciences, and the ability to lead cross-functional teams effectively to achieve compliance...Regulatory
- ...Senior Manager, North America Regulatory Liaison. This hybrid role... ...will drive NA regulatory strategy for Immunology projects, partnering with global leaders. You will lead end-to-end planning, coordination... ...guiding teams through submissions and Health Authority interactions...Regulatory
- ...are searching for the best talent for a Vice President, Global Commercial Disease Area Strategy (DAS) Leader, Auto-Antibody, Maternal Fetal and Rheumatology... ...against the Johnson and Johnson Immunology goals. Lead the business development strategy, provide commercial expertise...Local area
6085-Janssen Global Services, LLC Legal Entity
Horsham, PA4 days ago - ...Senior Medical Director, Oncology Safety to lead clinical safety and pharmacovigilance strategies for oncology assets within Global Safety. You will supervise safety data... ...matrix, mentoring colleagues and shaping regulatory deliverables. Hybrid work model with on‑site...Regulatory
- Americhem is a globally recognized designer and manufacturer of custom... ...'s global Healthcare market strategy. Drive the evaluation and... ...to deliver innovative, market-leading solutions. Integrate customer... ...needs, competitive intelligence, regulatory requirements, and...Regulatory
$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage... ..., scientifically sound, global, integrated regulatory vision/strategies for assigned product/s... ...deliverables (including leading assigned tasks) while fostering... ...required for submission and supports response to...RegulatoryFull timeWorldwideRelocation package- Johnson & Johnson in Horsham, PA seeks a Vice President, Global Commercial Disease Area Strategy Leader for Auto-Antibody, Maternal Fetal and Rheumatology. The role leads end-to-end strategy and portfolio decisions across global markets and collaborates with R&D, Medical...
- At Blue Cross Blue Shield Global Solutions (BCBS Global Solutions... ...possibilities. Summary The Director & Lead Actuary will serve as the... ...Lead pricing strategy and model development for international... ...Prepare actuarial opinions, regulatory filings, and related documentation...RegulatoryRemote jobWork at officeWorldwide
- A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality...RegulatoryFor contractorsRemote work
- ...cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product... ..., alignment of labeling text with data, regulatory requirements, consistency (where appropriate... ...implementation of the global labeling strategy including the development of target labeling...RegulatoryWork at officeImmediate startFlexible hours
$117k - $201.25k
Job Function Regulatory Affairs Group Job Sub Function... ...for Regulatory Agency submissions. For CTA/INDs - Ensure... ...documents and submission strategies in preparation for... ...of NDA, MAA (and other global filings) as assigned (... ...responsible for organizing and leading meetings. Provide...RegulatoryImmediate startFlexible hours- Merck & Co. is seeking a Regulatory Affairs Headquarters Principal Scientist located... ...Wales, PA. This role involves developing global regulatory strategies for vaccines and infectious diseases,... ...contact for regulatory matters, and leading cross-functional teams. The ideal...Regulatory
$117k - $201.25k
...Principal Scientist (Manager), Global Regulatory Affairs, CMC Purpose: The... ...developing global CMC regulatory strategies and dossier content plans... ...responsibility is to lead the CMC regulatory activities... ...Regulatory Team(s) to develop global submission plans that comply with local...RegulatoryLocal area- ...oversee a divisional compliance team and ensure regulatory alignment across our technology landscape.... ...You will direct IT operational compliance, lead strategy for large-scale investments, and collaborate with Quality, Global Engineering, and the GRC team to align...Regulatory
$142.4k - $224.1k
...Associate Director of HCP Strategy for HIV Daily... ...Owner (MPO) and Team Lead for US HIV Treatments... ...those involving OPDP submission Partner with Analytics... ...with Legal, Medical, Regulatory, Compliance, agency partners... ...Overview Our company is a global health care leader...RegulatoryDaily paidFor contractorsLocal areaRelocationVisa sponsorshipShift work- ...division seeks a senior SAS programmer to lead statistical programming for late‑stage... ..., listings and figures across trials and regulatory submissions. You will collaborate with statisticians and stakeholders, coordinate global programming activities and mentor a team...Regulatory
$199k - $343.85k
...treatments and cures. We lead where medicine is... ...studies that are part of a global compound development... ..., Statistics, Regulatory, QMMC, and GMS to ensure... ...relating to the overall strategy and operational implementation... ...research, including submission to health authorities....RegulatoryFull timeContract workWork experience placementImmediate startJohnson & Johnson Innovative Medicine
Spring House, PA1 day ago$131k - $210k
...are looking for a dedicated Lead Architect to join our talented... ...assure compliance with legal, regulatory, and IPS project requirements... ...Hathaway company, is a global leader in technical consulting... ...Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing...RegulatoryFor contractorsWork at officeFlexible hoursIPS-Integrated Project Services, LLC
Blue Bell, PA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy & Submissions Lead. Be the first to apply!
