Current jobs related to CMC 2 Regulatory affairs - Rahway - Katalyst Healthcares and Life Sciences
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Lead CMC Regulatory Affairs Specialist
1 week ago
Rahway, New Jersey, United States Insight Global Full time**Become a Key Player as a Lead CMC Regulatory Affairs Specialist** Insight Global is in search of a committed professional to join the Global Regulatory Affairs division of a leading pharmaceutical organization. **Key Responsibilities Include:** Crafting comprehensive CMC regulatory approaches Preparing a variety of regulatory CMC documents including...
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Lead Regulatory Affairs Specialist
7 days ago
Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeKey Responsibilities and Qualifications: Independently contribute to new product development teams by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions concerning IVD medical devices, emphasizing instrumentation and software/hardware, alongside experience in assay development. Proven...
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Lead Regulatory Affairs Specialist
7 days ago
Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeKey Responsibilities and Qualifications: Independently assist core teams in the development of new products by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions related to IVD medical devices, emphasizing instrumentation and software/hardware, along with experience in assay development....
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Senior Regulatory Specialist
2 weeks ago
Rahway, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities and Requirements: utonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instrumentation and...
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Executive Director, Structure Characterization
2 months ago
Rahway, United States Merck & Co. Full timeThe Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep structural understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch and into supply for...
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Senior Documentation Specialist
2 months ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...
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Senior Documentation Specialist
4 weeks ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...
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Oncology Portfolio Project Manager
4 weeks ago
Rahway, United States NavitsPartners Full timeJob DescriptionJob DescriptionJob Title: Oncology Portfolio Project ManagerLocation: Rahway, NJ 07065Duration: 12 MonthsJob Description:Ensure robust engagement among global, regional, and local markets on Oncology New Product.Monitor and update GRL approach: Track and provide visibility (next 1-2 years) of evolving Pan, Early, Launch global commercial team...
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Quality Control Analytical Chemist
1 week ago
Rahway, New Jersey, United States Astrix Inc Full timeAstrix Inc. is a prominent player in the pharmaceutical sector, focused on pioneering drug solutions that enhance patient care. Our commitment to scientific integrity and stringent quality protocols is evident in every facet of our operations. Position Overview: We are in search of a dedicated Analytical Chemist to become an integral part of our team. The...
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Oncology Marketing Project Coordinator
7 days ago
Rahway, New Jersey, United States Mindlance Full timePosition: Marketing Project ManagerLocation: RemoteContract Duration: 12 Months with Potential for ExtensionCompensation: $45/hr on W2Essential Qualifications:Experience in Marketing Product Launch3-5 years in Project/Program ManagementBackground in the Pharmaceutical SectorExperience in OncologyRole Overview:• Facilitate strong collaboration among global,...
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Analytical Chemist
2 months ago
Rahway, United States Astrix Full timeOur client is a leading pharmaceutical company dedicated to developing innovative drug products that improve patient outcomes. They are committed to scientific excellence and rigorous quality standards in all aspects of our operations.Location: Rahway, NJSchedule: Mon-Fri 8:30 a.m. - 5 p.m.Pay: $27.39/hrJob Type: 1-year Contract Position Overview: We are...
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Analytical Chemist
2 months ago
Rahway, United States Astrix Full timeOur client is a leading pharmaceutical company dedicated to developing innovative drug products that improve patient outcomes. They are committed to scientific excellence and rigorous quality standards in all aspects of our operations.Location: Rahway, NJSchedule: Mon-Fri 8:30 a.m. - 5 p.m.Pay: $27.39/hrJob Type: 1-year Contract Position Overview: We are...
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Marketing Project Manager
3 weeks ago
Rahway, United States Mindlance Full timeTitle: Marketing Project ManagerLocation: Rahway, NJDuration: 12 Months with Possible ExtensionPay Rate: $45/hr on w2Must Have:Marketing Product launch exp Project/Program management (3-5 years)Pharmaceutical industryOncology Exp.Job Description:• Ensure robust engagement among global, regional, and local markets on Oncology New Product.• Monitor and...
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Marketing Project Manager
3 weeks ago
Rahway, United States Mindlance Full timeTitle: Marketing Project ManagerLocation: Rahway, NJDuration: 12 Months with Possible ExtensionPay Rate: $45/hr on w2Must Have:Marketing Product launch exp Project/Program management (3-5 years)Pharmaceutical industryOncology Exp.Job Description:• Ensure robust engagement among global, regional, and local markets on Oncology New Product.• Monitor and...
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Nursing Assistant
4 days ago
Rahway, New Jersey, United States RWJBarnabas Health Full timeJob SummaryThe Nursing Assistant provides care in the healthcare system within the scope of practice defined by regulatory standards and assures awareness of ethical standards of practice as defined by the American Nurses Association code of ethics.The Nursing Assistant assures safety in practice and is inclusive of the principles of evidence-based practice...
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Nursing Assistant
4 days ago
Rahway, New Jersey, United States RWJBarnabas Health Full timeJob SummaryThe Nursing Assistant provides care in the healthcare system within the scope of practice defined by regulatory standards and assures awareness of ethical standards of practice as defined by the American Nurses Association code of ethics.The Nursing Assistant assures safety in practice and is inclusive of the principles of evidence-based practice...
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Marketing Project Manager
4 weeks ago
Rahway, NJ, United States inSync Staffing Full timeMarketing Project Manager$45.00-$48.85/hr8am-5pm Mon-FriOnsite: Rahway, NJ1 year assignmentSeeking a Project Manager to join the Global Marketing Oncology New Products Team. You will work in the commercial organization and play an integral role in overseeing the new product global-region-local engagement and supporting the new product Enterprise Go to Market...
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Rahway, United States RWJ Barnabas Full timeJob Summary The Nursing Assistant provides care in the health care system within the scope of practice defined by regulatory standards and assures awareness of ethical standards of practice as defined by the ANA code of ethics. The NA assures safety in practice and is inclusive of the principles of evidence based practice by maintaining a realization of own...
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Scientist - II (Associate)
1 month ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Scientist - II (Associate) . This is a 12+ Months Contract opportunity with long-term potential and is located in Rahway, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:24-34954Pay Range: $30 - $35/hour. Employee benefits include, but are not limited to, health insurance...
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Product Development Engineer
2 days ago
Rahway, United States Insight Global Full time*This is a 6-month contract with extensions to a year+*One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management lead, supporting the Combination Product, Device Development Team. This project is focusing on autoinjectors and they will be responsible for leading and implementing Medical Device & Combination Product...
CMC 2 Regulatory affairs
3 months ago
- Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States.
- Manage execution / authoring and review of CMC documentation (Module 1, 2 and 3 / Part II) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports.
- Experience in reviewing CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guideline.
- Knowledge of relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications.
- Ph. Eur requirements for veterinary products and guidance (not limited to QRD veterinary template, guideline on SPCs for antimicrobials, MRL etc.)
- Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.
- Review of artworks / labelling, SmPC and pack insert.
- Comparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPC.
- Evaluation and Assessment of change control and develop a plan with timeline to implement the same.
- Knowledge and experience on reviewing the DMF and assessment of Drug substance related changes, gap analysis and authoring of corresponding variation packages.
- Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management.
- Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
- Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders.
- Deliver all regulatory milestones as per agreed SLAs with clients.
- Identify, communicate, and escalate potential regulatory issues / risks and propose mitigation.
- Experience should be 4 to 7 years.
- Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred).
- Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.
- Knowledge and hands on experience on Animal Health CMC.
- Marketing authorization experience.
- Proven Project Management experience.
