Regulatory Affairs Manager jobs in Somerset, NJ
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SENIOR MANAGER, REGULATORY AFFAIRS - GENERAL MEDICINE
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...
| Company | Biospace |
|---|---|
| Address | Basking Ridge, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | a week ago See detail |
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...
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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...
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Manager Regulatory Affairs
Teva Pharmaceuticals
Parsippany, NJ
Requires a Bachelors degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage form experience...
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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...
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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...
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Manager Global CMC Regulatory Affairs
Johnson & Johnson
Titusville, NJ
Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...
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Associate Director, Regulatory Affairs (Advertising and Promotion)
Bausch Health
Bridgewater, NJ
Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...
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VP/TA Head, General Medicine - Global Regulatory Affairs
Merck
Rahway, NJ
Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...
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USA Regulatory Affairs Specialist Project Lead I Scientific
Adecco
Bridgewater, NJ
$ 88 - $ 89.22 / Hour
Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Clinical Trial Manager, Global Oncology Medical Affairs
Biospace
Basking Ridge, NJ
Support the preparation, set-up, and execution and reporting of all Global Oncology Medical Affairs operations Clinical Trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP G...
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Medical Affairs Operations Senior Manager-Americas (Hybrid)
Csl
Summit, NJ
Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement. . Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and...
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Associate Director, Medical Affairs - Program Management
Merck
Rahway, NJ
Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.. Facilitate the creation and approval of all project deliverables, including maintaining d...
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Summer 2024 - Regulatory Portfolio Management Internship
Bristol-Myers Squibb Company
Princeton, NJ
Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability d...
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Senior Manager, Product Communications and Public Affairs, Pulmonary Hypertension
Johnson & Johnson
Titusville, NJ
Develop and implement innovative communication and Public Affairs strategies and programs in support of brand business objectives for UPTRAVI, OPSUMIT, OPSYNVI. Lead the growth of unbranded social communities and content creat...
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Regulatory Compliance Senior Manager - Parsippany, NJ
Teva Pharmaceuticals
Parsippany, NJ
Responsible to execute the formal market action decision as dictated by Senior Quality Unit Management and the Market Action Committee and author Product Recall Letter. Circulate draft Recall Letter to Quality Unit Management for...
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Regulatory Associate Technical Manager
Givaudan
East Hanover, NJ
Manage the end-to-end lifecycle of electronic regulatory documentation templates. Identify enhancements of existing solutions with the intent support critical business needs. Build reusable tools to streamline the CoE operational...
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Regulatory Associate Technical Manager
Givaudan Roure United States
East Hanover, NJ
Manage the end-to-end lifecycle of electronic regulatory documentation templates. Identify enhancements of existing solutions with the intent support critical business needs. Build reusable tools to streamline the CoE operational...
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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...
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