Regulatory Affair Specialist jobs in New Brunswick, NJ
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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 weeks 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 weeks ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
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...
3 days 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...
3 days ago seen See more...
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 weeks ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
Associate Manager, Regulatory Affairs (Hybrid) New
Iff Family Of Companies
Hazlet, NJ
Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...
4 hours ago seen See more...
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Manager, Regulatory Affairs- North America (Hybrid) New
Iff Family Of Companies
Hazlet, NJ
Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...
20 hours ago seen See more...
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Associate Director, Regulatory Affairs
Bausch + Lomb
Bridgewater, NJ
Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...
a month ago seen See more...
- View all Bausch + Lomb jobs - jobs in Bridgewater, NJ
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...
a week ago seen See more...
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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...
6 days 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...
6 days 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...
a week ago seen See more...
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Associate Director, Regulatory Affairs
Johnson And Johnson
Somerville, NJ
Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....
a month ago seen See more...
- View all Johnson And Johnson jobs - jobs in Somerville, 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 weeks 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 weeks ago seen See more...
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SENIOR MANAGER REGULATORY AFFAIRS
Tk-Chain Llc
Princeton, NJ
$80,000 - $170,000 a year
Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...
a month ago seen See more...
- View all Tk Chain Llc jobs - jobs in Princeton, NJ
Associate Director / Director, Regulatory Affairs (Generic Medicines)
Cnam - Auditeurs - Accueil
Princeton, NJ
This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...
a month ago seen See more...
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Associate Manager, Regulatory Affairs
Kenvue
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
a month ago seen See more...
- View all Kenvue jobs - jobs in Skillman, NJ
Associate Manager, Regulatory Affairs
Johnson & Johnson Consumer Inc.
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
a month ago seen See more...
Associate Director, Regulatory Affairs - Labeling: Job ID - 1297NJ
Ascendis Pharma
Princeton, NJ
Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance....
2 months ago seen See more...
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Director, Global Regulatory Affairs (GRL)
Biospace
Basking Ridge, NJ
Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...
4 weeks ago seen See more...
- View all Biospace jobs - jobs in Basking Ridge, NJ
Director, Regulatory Affairs Companion Diagnostics
Biospace
Basking Ridge, NJ
CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...
4 weeks ago seen See more...
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Associate Director, US Regulatory Affairs Strategy
Daiichi Sankyo, Inc.
Basking Ridge, NJ
Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...
a month ago seen See more...
Manager, Regulatory Affairs - Regulatory Project Manager
Daiichi Sankyo, Inc.
Basking Ridge, NJ
$117K - $148K a year
Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background M...
2 months ago seen See more...
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