Regulatory Affairs Specialist III

Regulatory Affairs Specialist Project Lead I Location: Bridgewater, NJ (Fully Remote)Duration: Contract till Oct 2024 with possibility to extendFully RemoteThis role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation. Experience in Immunology products is preferred, but any ADCOM experience will be considered.Education and...

Job Description: Pay Range: $87.41hr - $92.41hr Responsibilities: This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. dditionally, this role leads...

Job Description: Pay Range: $90.41hr - $92.41hr Responsibilities: Experience in Immunology products is preferred, but any ADCOM experience will be considered. Education and Experience: BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related...

Job Title: Regulatory Affairs Specialist Project Lead ILocation: REMOTEDuration: 06 months with possible extensionSUMMARYFully Remote, open to candidates in all US time zones.However, must be able to work M-F 8 AM - 5 PM ET time zone.Possibility for an extensionTop 3 Must Have:• Leadership capabilities and ability to work with cross-functional team•...

Job Title: Regulatory Affairs Specialist Project Lead ILocation: REMOTEDuration: 06 months with possible extensionSUMMARYFully Remote, open to candidates in all US time zones.However, must be able to work M-F 8 AM - 5 PM ET time zone.Possibility for an extensionTop 3 Must Have:• Leadership capabilities and ability to work with cross-functional team•...

Job DescriptionJob DescriptionSummaryThis position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain...

SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with...

SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with...

SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with...

Fully Remote This role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation. Experience in Immunology products is preferred, but any ADCOM experience will be considered. Education and Experience: " BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or...

We are looking for a VIE - Quality & Regulatory Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity.Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your application.Your responsibilities:Customer Request &...

We are looking for a VIE - Quality & Regulatory Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity. Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your application. Your responsibilities: Customer Request & Complaints: ...

Medical Information Specialist I (Clinical) Bridgewater, NJ-Hybrid Role 3-month extension Pay Rate: $45-55/hr on w2 Hybrid Role Possibility of a 3-month extension Pharm D Required Open to candidates willing to relocate at their own expense The position may include travel to 1 conference (reimbursement offered) Must-Have: 1+ years in medical information,...

Job Description:• Undergraduate degree in business administration/Engineering degree: in Supply Chain Management, Finance, or related field. • At least 5-7 years proven experience in Risk Management and/or procurement, supply chain management, within the pharmaceutical or healthcare industry. • Strong understanding of procurement processes, supplier...

Job DescriptionJob DescriptionSolaris Pharma Corporation is a leading generic corporation with the vision of improving the patients quality of life through development of niche pharmaceutical products. Solaris Pharma Corporation has a fully equipped Research & Development facility with expertise in the development of generic and specialty products. Solaris...

Job DescriptionJob DescriptionSolaris Pharma Corporation is a leading generic corporation with the vision of improving the patient’s quality of life through development of niche pharmaceutical products. Solaris Pharma Corporation has a fully equipped Research & Development facility with expertise in the development of generic and specialty products....

Director, Head of Clinical Quality Assurance (GCP, GLP) This position reports to the CEO, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate. Education and Credentials College degree in...

Who Are We? Taking care of our customers, our communities and each other. That’s the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 160 years. Join us to discover a culture that is rooted in innovation and thrives on collaboration. Imagine...

Company Description: Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are...

Company Description: Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are...