Regulatory Affairs Manager jobs in New Jersey

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ASSOCIATE MANAGER, REGULATORY AFFAIRS (HYBRID)

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...

CompanyIff Family Of Companies
AddressHazlet, NJ
CategoryInformation Technology
Date Posted 21 hours ago See detail

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...

Manager, Regulatory Affairs- North America (Hybrid)

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...

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...

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...

Manager, Reg Affairs NAM New

Iff Family Of Companies

Ridgefield, NJ

Responsible for the preparation of regulatory submissions including GRAS dossiers, NDIN, Master Files, FSRN and other relevant regulatory documents or submissions. Collaborate with internal IFF Global Regulatory Strategy Lead and...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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/...

Quality and Regulatory Manager Nutraceuticals

Ashland, Llc

Kearny, NJ

Develops, implements, monitors, and continuously improves programs to ensure compliance with industry standards for food and dietary supplements (cGMP, 21 CFR 111, 117, HACCP, FSMA, SQF, etc.). Supports customer & other regulator...