Regulatory Affairs Associate Jobs in New Jersey

213 jobs

JOB DESCRIPTION Location: US-NJ-Raritan More information about this job: The Company: Ortho Clinical Diagnostics (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 3,800 employee...

We currently have an excellent opportunity for a Regulatory Affairs Associate located at our Princeton, NJ location. The Regulatory Affairs Associate possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned. Responsible for electronic reporting and registration activities and provides support for regulatory submission act...

Our client is a major medical device company and is seeking seasoned Regulatory Affairs professionals with either PHARMA OR MED DEVICE experience within RA. There are currently 2 openings and the manager is looking to fill these roles ASAP. If interested and qualified, please apply today to receive a call from a recruiter with more information! These are 6mo+ contract positions with possibility t...

Regulatory Affairs Associate CMC Position Overview Our client is a biopharmaceutical company that specializes in life saving therapies derived from human plasma. The Regulatory Affairs Specialist – CMC ensures regulatory compliance by determining submission requirements for development projects and review of CMC changes to current marketing applications. The Regulatory Affairs Associate Director...

Regulatory Affairs Associate – CMC: Near Edgewater, NJ area Position Overview Regulatory Affairs Specialist – CMC: Ensures regulatory compliance by determining submission requirements for development projects and review of CMC changes to current marketing applications. The Regulatory Affairs Associate Director – CMC is also responsible for providing information to cross-functional team members t...

Job Description : Contract position for a Regulatory Affairs Associate for medical devices. Work with international Regulatory Affairs (RA) affiliates regarding labeling changes. Initiate, review and approve labeling changes for RHQ change. Work with international RA affiliates to strategize on RA pathway in their respective markets. Participate on product development teams to ensure US and E...

Regulatory Affairs Associate – CMC: Near Edgewater, NJ area Position Overview Regulatory Affairs Specialist – CMC: Ensures regulatory compliance by determining submission requirements for development projects and review of CMC changes to current marketing applications. The Regulatory Affairs Associate Director – CMC is also responsible for providing information to cross-functional team members t...

Our client provides innovative contract manufacturing services for OTC and skin treatment products. The Regulatory Affairs Associate will work with the R&D team in their Northern New Jersey facility. Responsibilities Ensure all products meet the stringent standards and regulations of the global and US cosmetics market as well as the blacklist of various customers. Be familiar with USA (FDA and ...

Awarded the industry's top honors every year since 1994, Davalyn Corporation is one of the most reliable names in the recruiting industry. Founder Richard K. Sinay opened the company's doors on December 18, 1989 and has since become a model to offices nationwide emphasizing the important principles of professionalism, hard work, and accurate representation in creating lasting client partnerships. ...

Requirements: - BA/BS in Scientific discipline required. Engineering strongly preferred - 510(k), IDE, PMA (original/revision/supplements) preparation - Minimum 2 years’ experience in FDA regulated industry - Working knowledge of Medical Device Regulations (FDA required, international a plus) - Proficiency with MS Office required, strong MS Excel knowledge preferred Responsibilities: - Ensu...

Mondelēz International is a whole new company that has been reimagined with a single focus in mind: create delicious moments of joy by sharing the world’s favorite brands. Launched on Oct. 1, 2012, and employing around 100,000 people around the world, Mondelēz International comprises the global snacking and food brands of the former Kraft Foods Inc. While Mondelēz International is new, our brands...

Description Mondelēz International is a whole new company that has been reimagined with a single focus in mind: create delicious moments of joy by sharing the world’s favorite brands. Launched on Oct. 1, 2012, and employing around 100,000 people around the world, Mondelēz International comprises the global snacking and food brands of the former Kraft Foods Inc. While Mondelēz International is ne...

Job Summary: The Regulatory Associate will assist the Associate Director of Regulatory Affairs in the creation of ANDA and other regulatory submissions to the FDA, develop strategies to guide IGI Labs in the timely creation of regulatory submissions and keep current in regulatory laws and processes. Reporting Relationships: Individual Contributor Essential Responsibilities: Assist in the trans...

About us Description Establish and maintain contact with each worldwide region Regulatory contact in order to: Negotiate and establish international product submissions (new registrations and re-registrations) that are aligned with that region’s/country’s and BD PAS’ integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans. Monitor, track and report back to ...

Job Summary: Provide regulatory guidance and strategy to Integrated Project Teams (IPT’s) and other functional teams leading to sound scientific development programs and successful registration for new compounds and new indications for biotechnology-based therapeutics. Interact with functional groups regarding the development of CMC regulatory strategies and strategic RACMC advice. Represent Daiic...

Establish and maintain contact with each worldwide region Regulatory contact in order to: Negotiate and establish international product submissions (new registrations and re-registrations) that are aligned with that region’s/country’s and BD PAS’ integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans. Monitor, track and report back to the Director, Regulator...

Role Description Summary The function of this position is to review and provide regulatory comments on technical documents. To attend meetings, provide regulatory guidance, receive and review documents, prepare the regulatory submissions and submit to FDA. Description of KEY responsibilities (describe the main results of the job to be achieved): Thorough review of technical documents Prepare a...

Role Description Summary The function of this position is to review and provide regulatory comments on technical documents. To attend meetings, provide regulatory guidance, receive and review documents, prepare the regulatory submissions and submit to FDA. Description of KEY responsibilities (describe the main results of the job to be achieved): Thorough review of technical documents Prepare and ...

Overview: We currently have an excellent opportunity for a Regulatory Affairs Associate located at our Princeton, NJ location. The Regulatory Affairs Associate possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned. Responsible for electronic reporting and registration activities and provides support for regulatory sub...

Description 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 g...