Global Regulatory Submissions Lead
Glaxosmithkline
GlaxoSmithKline is seeking a Regulatory Affairs Specialist to lead the planning and compilation of regulatory registration requirements. This hybrid position based in Upper Providence, Delaware County, involves collaborating with global submission teams and ensuring timely delivery of high-quality submissions. The ideal candidate will have a Bachelor's degree and at least 3 years of experience in regulatory affairs, showcasing strong communication skills and a keen attention to detail. #J-18808-Ljbffr GlaxoSmithKline
- Women In Bio seeks a Regulatory Affairs Specialist to lead the planning and delivery of regulatory submission dossiers in the United States. You will collaborate with teams across clinical, CMC, quality, and regulatory functions, ensuring timely submissions that align...RegulatoryWork at officeRemote work
- ...disease together. Position Summary You will lead planning, compilation and delivery of regulatory registration requirements for investigational and lifecycle activities globally. You will work closely with global submission teams, clinical, CMC, quality, publishing and...RegulatoryWork at officeLocal areaRemote work
- 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
- ...Collegeville, Pennsylvania, is seeking an experienced CMC Regulatory Professional to lead regulatory strategy for product development and... ...involves cross-functional collaboration to prepare regulatory submissions and ensure compliance. The ideal candidate has over 6 years...Regulatory
- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...compliance with FDA expectations and global standards. Prepare and review... ...., with a focus on IND and BLA submissions to the FDA. Experience as a...RegulatoryLocal area
$113.85k - $189.75k
We are a global biopharma company with bold ambitions to positively impact... .... Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...U.S., focusing on IND and BLA submissions to FDA. Experience as a U.S. liaison...RegulatoryLocal area- CSL Plasma Inc. is seeking an Associate Director, Regulatory Project Manager for a hybrid role with key... ...King of Prussia, PA; and other locations. You will lead end‑to‑end regulatory initiatives, coordinate submissions, and drive governance across regulatory operations...Regulatory3 days per week
- ...driving strategic financial decisions across a global organization. This position offers the... ...'ll Do Financial Analysis & Forecasting Lead complex financial modeling, forecasting,... ...advisor across accounting, finance, and regulatory functions. Develop and present executive‑...Regulatory
- ...Pharmaceutical Services, Inc is hiring a Principal Regulatory Affairs Project Manager based in Exton,... ...candidate will drive the regulatory submission process, ensuring integration with... ...Competitive salary and the opportunity to shape global regulatory strategy await! #J-18808-...Regulatory
- Initial Therapeutics, Inc. is seeking a Sr. Director, Head of Global Labeling Strategy to lead the Global Labeling strategy function. This leadership... ...managing a global team and ensuring compliance with regulatory standards while developing innovative labeling strategies...Regulatory
- GlaxoSmithKline is looking for a Regulatory Affairs Specialist in Upper Providence, Delaware, to lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy... ...of CMC regulatory experience focused on FDA submissions. The role combines on-site and remote work, fostering...RegulatoryRemote work
$33.12 - $55.19 per hour
...quality and professional development. Lead others, monitor resources, provide input... ...Assistant supporting executive leadership in a global organization Knowledge of the... ...to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue...RegulatoryHourly payPermanent employmentH1bWork at officeLocal areaVisa sponsorshipWork visaRelocation packageWeekend work2 days per week- Position Summary Lead CMC (Chemistry, Manufacturing and Controls... ...process development, global file review/launch, and completion... ...supply chain/quality and CMC regulatory approaches; generate options/... ...contributing to CMC regulatory submission sections. Strong decision-making...RegulatoryContract work
$200.25k - $333.75k
Position Summary You will lead molecule stewardship for small molecule... ...development, analytics, regulatory, manufacturing and external... ...evidence support for regulatory submissions and inspections. Drive... ...matrix environment. Knowledge of global regulatory expectations for pharmaceutical...RegulatoryContract workLocal areaRemote workFlexible hours- A leading recruitment agency in the United States is seeking an experienced candidate to assist with Inspection Readiness Preparation.... ...opportunity for someone looking to advance within the pharmaceutical and biotechnology sectors. #J-18808-Ljbffr PSG Global Solutions
- SEI Investments Developments in Oaks, Pennsylvania is looking for a Compensation Manager to optimize global compensation programs for sales and corporate groups. This role combines analytics with strategic implementation while ensuring compliance with governance standards...
- GSK in Collegeville, PA is seeking a CMC Regulatory Affairs professional to lead regulatory strategy for mature vaccine projects. This role involves ensuring compliance with FDA regulations and collaborating with teams across development and lifecycle management. The ideal...Regulatory
- ...Committee, oversee fund governance, and ensure compliance with regulatory standards. We require a Bachelor's degree in Finance and 5-7 years... ...experience in fund administration. As a key player, you will lead valuation reviews, organize board reporting, and document...RegulatoryFlexible hours
- ...AtPresidio, we're at the forefront of a global technology revolution, transforming industries... ...opportunity for a Security Practice Lead to join our Cybersecurity National Practice... ...Broad experience and understanding of regulatory framework and guidelines in the region are...RegulatoryFor contractorsLocal area
$12 - $17 per hour
...Team Lead Share Apply Part-time $12.00 - 17.00 per hour The Team Lead is responsible for managing restaurant operations, in... ...quality while ensuring compliance with policies, procedures, and regulatory requirements: Trains, develops, coaches, and evaluates employee...RegulatoryHourly payPart timeFlexible hours- West Pharmaceutical Services, Inc seeks a Senior Counsel, Compliance, Regulatory & Quality in Exton, PA. This strategic role offers integrated legal leadership across global Compliance, Regulatory Affairs and Quality Assurance functions. The incumbent will ensure compliance...Regulatory
- A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities in... ...requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in...RegulatoryContract work
- ...Zenitech is a leading technology solutions provider dedicated to reshaping the global digital landscape. Headquartered in the UK, Zenitech operates internationally... ...secure, and aligned with relevant standards and regulatory requirements. Support pre‑sales activities,...RegulatoryPermanent employmentRemote workFlexible hours
- ...and execution of Fresenius Medical Care's global physical security program across... ...Prevention & Behavioral Threat Assessment Lead enterprise-wide Workplace Violence Prevention... ...Ensure investigative processes meet legal, regulatory, and evidentiary standards. Oversee...RegulatoryLocal area
- ...Consultants is seeking an experienced Senior Project Environmental Specialist to lead siting, permitting, and documentation for electric transmission projects. You will coordinate with clients and regulatory agencies, prepare proposals, estimate costs, and guide quality control...Regulatory
- ...Position Overview The Shift Lead role at Spotless Brands is an operational support position designed to provide high performing... ...responsibilities) Must meet all required certification and regulatory compliance standards applicable to the role as defined by federal...RegulatoryLocal areaShift workAfternoon shift
- CSL Plasma Inc. is seeking a Head of Global Regulatory Affairs CMC to oversee regulatory strategy and operations. This role is critical in developing... ...background in biological sciences, and the ability to lead cross-functional teams effectively to achieve compliance and...Regulatory
- Chesterbrook Academy in Collegeville, Pennsylvania, seeks a Principal to lead their early childhood education program. The ideal candidate... ..., establishing a positive school culture, and ensuring regulatory compliance. With a focus on educational excellence, the Principal...Regulatory
- Position Summary Lead small molecule drug substance activities from lab development through... ...teams in process development, quality, regulatory, manufacturing and supply to deliver... ...in late‑stage development, regulatory submissions or supporting regulatory interactions....RegulatoryContract workLocal areaRemote work
- ...vision, roadmap, and long-term strategy aligned with business goals Lead design, development, deployment, and lifecycle management of AI... ...Ensure AI solutions comply with data privacy, security, regulatory, and ethical AI guidelines Oversee AI platform architecture, model...Regulatory
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