Regulatory Affairs Associate Jobs in New Jersey

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301 New Jersey Regulatory Affairs Associate jobs found on Monster.

Jobs 1 to 20 of 301
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we l...
REGULATORY AFFAIRS SPECIALIST BA/BS in Scientific discipline required. Engineering strongly preferred RAC certification desired Ensure compliance to all internal, US, EU and other international requirements and corporate policies and procedures for market approval of medical devices/combination products. Apply scientific principles to understanding safety and efficacy on a wide range of produc...
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we l...
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we l...
Regulatory Affairs Associate (CMC) Piscataway, NJ Premiere pharmaceutical organization is seeking a Regulatory Affairs Associate to join their growing Regulatory Affairs team. This is a full time permanent opportunity that offers career growth, strong salary and benefits! The Regulatory Affairs Associate prepares, reviews and submits high quality annual reports with FDA within Annual report tim...
Our client is currently seeking a Regulatory Affairs Specialist This job will have the following responsibilities: Ensure compliance to all internal, US, EU and other international requirements and corporate policies and procedures for market approval of medical devices/combination products. Apply scientific principles to understanding safety and efficacy on a wide range of products. Prepare d...
Senior Manager / Associate Director Regulatory Affairs My client is a small, startup company focused on treating rare neurological disorders. They are growing rapidly and are in need of a talented Senior Manager or Associate Director of Regulatory Affairs. You will be the right arm of the Vice President of Regulatory Affairs, managing agency requests related to pipeline development activities. In...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated ...
Our client is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years, they have expanded beyond the traditional European base, with over 5,000 employees worldwide, it operates subsid...
REGULATORY AFFAIRS MANAGER RA Manager will manage regulatory activities and collaborate with the project team to develop regulatory strategies, milestones and submission deliverables for the New product filings, Prior approval and CBE Supplements. KEY RESPONSIBILITIES: Assist to ensure the successful preparation and filing of all regulatory submissions ANDA/NDAs, amendments/supplements, annual ...
JOB SUMMARY This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact wit...
Job Purpose Prepare, review and submit regulatory filings in support of BD&L, Due Diligence and OTC projects. Monitor and track information and requirement changes. Interact with regulatory agencies. Major Accountabilities Compiles and reviews ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions as needed in support of BD&L, Due Diligence, and OTC opportunities. Interacts e...
Position Title: Research Associate Legal, Economic & Regulatory Affairs (LERA) Location: Washington DC Position Overview: The LERA Associate based in Washington DC will work directly with LERA clients, serving as their specialized client service professional, and will report directly to head of LERA Research Management in DC. Our clients are leading public and private equity investors in the regio...
Leading Global Consumer Products / Pharma company Princeton, NJ
--RESPONSIBILITIES: • Review / approve Raw Material information for compliance with local, state, federal and internal regulations and SOPs • Review / approve formulations for compliance with local, state, federal and internal regulations and SOPs • Understand desired outcome and approve study release documentation • Generate / provide INCI lists • Review / approve associated manuscripts, pro...
Scientific Search Parsippany, NJ
REGULATORY ASSOCIATE II-Near Parsippany Job Summary: Compile, review and submit eCTD submissions to the FDA. Maintain indices, records and processes for all regulatory applications. Maintain GDUFA Self-Identification, User Fee and Establishment Registration processes. Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that Regulatory Agency receive timely and qu...
Location: Bridgewater, NJ Job Category: Regulatory Affairs Jobs Requisition Number: 70044627-51569JC Associate Director, Regulatory Affairs CMC-70044627-51569JC Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration...
Job Juncture, Inc. Jersey City, NJ
Sr. Regulatory Affairs Associate Our Client - a growing Pharmaceutical Company in NJ is looking for a Sr. Regulatory Affairs Associate. This position will be involved in preparing and submitting various regulatory filings. The Sr. Regulatory Associate will have frequent interaction with regulatory agencies. Primary Responsibilities will include: • Compiling and reviewing ANDAs, Amendments, Su...
Warner Chilcott Berkeley Heights, NJ
Celgene Corporation - Associate Director, Regulatory Affairs (Inflammation & Immunology) Job Forward to Friend or ColleaguePrint Location : Berkeley Heights, NJ Posted on : 3/14/2015 7:50:08 AM Position type : Full Time Job Code : 14002399 Areas of expertise : Regulatory Affairs - Regulatory Affairs Research and Development - Immunology Sales and Marketing - Marketing Medical Commu...
Adecco Employment Services Mahwah, NJ
Adecco Medical and Science is looking for a Regulatory Affairs Consultant for our client in Mahwah, New Jersey. This candidate will work with minimal supervision to review existing regulatory affairs files, identify areas for improvement, and initiate remediation activities. Collaborate with cross-functional teams to research product-related changes, generate new support documentation where needed...
Leading Global Consumer Products / Pharma company Skillman, NJ
--RESPONSIBILITIES: • Review / approve Raw Material information for compliance with local, state, federal and internal regulations and SOPs • Review / approve formulations for compliance with local, state, federal and internal regulations and SOPs • Understand desired outcome and approve study release documentation • Generate / provide INCI lists • Review / approve associated manuscripts, pro...

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