Full-Time Regulatory Affair Specialist jobs in New Jersey
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SPECIALIST - REGULATORY AFFAIRS
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
| Company | Biospace |
|---|---|
| Address | Plainsboro, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 2 months ago See detail |
Specialist - Regulatory Affairs
Biospace
Plainsboro, NJ
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
2 months ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
Senior Manager, Regulatory Affairs - General Medicine
Biospace
Basking Ridge, NJ
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...
2 weeks ago seen See more...
- View all - jobs in Basking Ridge, NJ
Senior Manager CMC Regulatory Affairs
Biospace
Basking Ridge, NJ
Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...
2 weeks ago seen See more...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
4 weeks ago seen See more...
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Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
a month ago seen See more...
- View all - jobs in Princeton, NJ
System Management & Regulatory Specialist
Pseg
Newark, NJ
Ensure proper execution of technical controls associated with regulatory compliance programs including NERC CIP, SOX, BPU and FERC Affiliate Restrictions. Manage patching cycles for workstations and servers associated with Securit...
a month ago seen See more...
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Regulatory Affairs Consultant
Katalyst Healthcares And Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...
a month ago seen See more...
Regulatory Affairs Consultant
Katalyst Healthcares & Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...
a month ago seen See more...
Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
2 months ago seen See more...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
2 months ago seen See more...
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Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
2 months ago seen See more...
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Director, Regulatory Affairs Strategy, Hematology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
2 months ago seen See more...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
2 months ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)
Laboratoire Guerbet
Princeton, NJ
Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...
2 months ago seen See more...
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Director, Regulatory Affairs - Pharmaceuticals
Stryker
Mahwah, NJ
Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...
2 months ago seen See more...
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Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance
Ferring Pharmaceuticals
Parsippany, NJ
Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...
2 months ago seen See more...
Technical Service and Regulatory Specialist
Tri-K Industries Inc
Denville, NJ
Responds to customer inquiries and solicits information as needed. Assists the sales and marketing with technical questions and requests. Assists in creation, dissemination and maintenance of TRI-K product technical documents. Mai...
2 months ago seen See more...
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Specialist - Regulatory Operations - Submissions
Biospace
Princeton, NJ
With direction from management participates on cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory submission obstacles, identifying emerging issues and pro...
2 months ago seen See more...
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Associate Director, Graduate Affairs Communications Specialist & CRM Administrator
Seton Hall University
Orange, NJ
The incumbent will assist with the general coordination of all graduate enrollment and recruitment efforts by providing critical strategic leadership where technology, data, reporting, and digital communications are concerned. M...
2 months ago seen See more...
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