Global CMC Regulatory Manager — Strategy & Submissions
Us Tech Solutions
US Tech Solutions in Madison, NJ seeks a CMC Regulatory Manager to provide strategic regulatory expertise across development through post-approval for biotech products. You will interface with Global Regulatory Sciences and related teams, guide change management, and ensure regulatory success for complex CMC submissions. The role emphasizes strong analytical skills, cross-functional leadership, and effective communication with Health Authorities, with a 6-month contract and potential extension. #J-18808-Ljbffr Us Tech Solutions
- ...Summary: The Client-CMC organization provides regulatory expertise related to... ...organization develop global regulatory CMC strategies and partner with key stakeholders... ...Health Authority submissions. The team also... ...products. The Client-CMC Manager is responsible for...SuggestedFull time
- Job-ID29499131Reference26-29348Scientific - Global Regulatory CMC Manager EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”Suggested
- ...development company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for... ...leaders to develop sound medical rationale and support regulatory submissions. Join us to make a significant impact in the medical domain....Suggested
- ...variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory...SuggestedImmediate start
- Daiichi Sankyo, Inc. in New Jersey, is seeking a Project Manager for Regulatory Affairs CMC to lead global dossier activities, manage schedules, resources, and risk mitigation across development and commercial products. The role emphasizes collaboration across functions...Suggested
$182k - $346k
...Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience) AbbVie's mission is to discover and deliver innovative medicines... ...with global regulatory requirements. Manages compounds through all phases of development,...Work at officeImmediate startRemote workWorldwideMonday to Friday- Shionogi Inc. in Florham Park, NJ, seeks a Senior Manager, Regulatory Affairs CMC to lead strategy and coordination of CMC regulatory activities under the... ..., and regulatory authorities to ensure compliant submissions and timely product development. The role requires five...
- ...Documentation & Compliance like 21 CFR Part 11/CGMP Ability to manage competing priorities Accuracy and Attention to Detail Schedule:... ...project management skills. Strong knowledge of cGMPs and domestic regulatory requirements Must complete tasks independently, notify manager...Contract workWeekend work
$90 - $100 per hour
...Job Title: Global Regulatory CMC Manager Location: 50% Onsite – Giralda Farms, NJ Duration: 6 Months... ..., supporting development, global submissions, manufacturing changes, and post-... ...regulatory risks, recommend mitigation strategies, and communicate potential impacts...Full timeContract workMonday to Friday- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Neuroscience to develop and implement global regulatory strategies across development and life-cycle stages. You will manage the GRPT, collaborate with LRST and AST, and lead risk assessment...
- Daiichi Sankyo US in New Jersey seeks a Global Regulatory Lead to shape regulatory strategy for development programs and represent regulatory in GPT meetings. You will guide submissions, align regional plans, and ensure Health Authority alignment across global programs....
$193.04k - $289.56k
...to "be an innovative global healthcare company contributing... ...Job SummaryThe Global Regulatory Lead (GRL) is... ...developing global regulatory strategy for assigned... ...including an understanding of CMC, supply chain and... ...and health authority submission documents.Serves as the...- ...Lead, guide, and train the CMC team to ensure highly qualified... ...which include, timely submission of Annual Reports, CPP, release... ...prior to new product launch Manage regulatory correspondence mainly to CDER... ...department. Coordinate with global and local affiliates. Education...Local area
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global regulatory strategies ensuring market approvals and lifecycle management for products. This role leads cross-functional teams, interfaces with LRST/AST, and advances...
$140k - $200k
The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor... ...for defining and executing global CMC regulatory strategies for assigned investigational... ...deliver scientifically sound, submission ready CMC content using a...Full timeWork at officeLocal area$127.28k - $190.92k
...to "be an innovative global healthcare company contributing... ...of the Project Manager (RACMC) function is to... ...with technical and regulatory standards. This role involves... ...generation and submission activities as a project... ....Coordinate biologics CMC change control activities...- Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ seeks a Senior Tax Manager to join the global tax team. You will lead U.S. federal/state filings, manage tax provisions, and support audits while coordinating with Finance, Operations, and Business teams. You’ll leverage...
$124.5k - $236.5k
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation... ...responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory...Full timeWork at officeRemote work- Shionogi is seeking a Senior Manager, Regulatory Affairs, Chemistry, Manufacturing, and Controls in Florham Park, NJ. The hybrid role blends strategic regulatory leadership with hands-on CMC submissions and compliance activities. You will coordinate cross-functional teams...
$174.1k - $287.27k
...DescriptionJOB DESCRIPTION: Sr. Director, Global Strategic InsightsJob Scope / Mission:... ...grounded insights that shape long-term strategy and enhance our competitive position. This... ...global organization. Stakeholder Management: Proven ability to work across functions...Full timeImmediate startRelocation packageShift work- ...is seeking a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory strategy from early development... ...cross‑functional teams across CMC, nonclinical, and clinical development... ...worldwide, authorship of submissions, and oversight of #J-18808-Ljbffr...Worldwide
- ...DescriptionResponsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy, including... ...responses.Drives coordination, planning, and submission of dossiers in assigned regions...Work at officeImmediate startWorldwide
$139.8k - $209.7k
Associate Director, US Regulatory CMC At Bayer we’re visionaries, driven... ...of CMC regulatory strategies to support the Bayer’s development... ...assigned US projects; Develops CMC submission materials for INDs and NDAs... ...on assigned projects; Manage virtual and/or cross functional...Work at officeLocal area2 days per week3 days per week$140k - $170k
Senior Manager, Regulatory Program Support (RPS) (Finance) Overview... ..., ensuring submissions and related activities... ...individual partners with the global regulatory lead and... .... Regulatory strategy, interpretation of health... ...(i.e., Development, CMC, Labeling, Advertising...Full timeWork at officeLocal areaShift work- ADP is seeking a Sr. Manager - Compensation in Parsippany-Troy Hills, NJ. The role requires over 10 years of experience, where you will... ...in compensation management are essential. Join ADP’s innovative Total Rewards team and help make a global impact. #J-18808-Ljbffr ADP
$150k - $200k
...Human by nature.Join us as our next Head of Systems Strategy - Regulatory, reporting to our Global Head of Regulatory Compliance & Digital Strategy. We... ...leadership, systems capability knowledge and project management to lead complex, projects within the Fragrance & Beauty...- ...BioSciences, Inc. is seeking an Associate Director of Regulatory Operations to drive global regulatory strategy and lead submission planning across regions. The role focuses on... ..., data governance, and lifecycle management while delivering training and process improvements...
- Shionogi Inc. seeks a GVP/GCP QA leader to support and maintain a robust quality program across PV and regulatory functions. You will collaborate with Global QA teams to oversee PV compliance, audits, and regulatory inspections, ensuring alignment with FDA/EMA/MHRA/PMDA...Work at office
$150k - $180k
...Global Trade Compliance DirectorIf you are a compliance professional... ...to lead global compliance strategy across the Fluid and Motion Control... ...for the development and management of the Americas FLMC Trade... ...FLMC locations.Participate in Regulatory Compliance strategic projects...Local area$133.2k - $172.37k
...based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia... ...~ Support preparation and submission of CMC regulatory filings... ...manufacturing, testing, control strategy, and lifecycle management.... ..., ensuring alignment with global regulatory requirements...Full timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
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