Regulatory Affairs Associate - FDA Submissions
Makro Scientific
A leading staffing solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the FDA. The ideal candidate will have a Master’s degree in Science and at least 3 years of experience in the pharmaceutical industry. Key responsibilities include coordinating submissions and maintaining regulatory databases. Strong communication and computer skills are essential for success in this fast-paced environment. Join a dedicated team and contribute to the success of life sciences companies. #J-18808-Ljbffr Makro Scientific
- Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals... ...documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards. The ideal...Suggested
- ...Talent. Job Description Description: The Regulatory Affairs Associate, with minimal guidance prepares,... ...submits high quality annual reports with FDA within Annual report timelines and in... ...documents for annual report submissions. Archive and maintain all post approval...Suggested
- Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate...SuggestedFlexible hours
- ...Role: Regulatory Affairs Associate Location: United States Duration: Long Term contract Position Summary... ...will assist in preparing regulatory submissions, maintaining regulatory documentation... ...registrations to ensure adherence to FDA and global regulatory standards. Key...SuggestedLong term contract
$117k - $120k
...Shift (Day) Job Description With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal...SuggestedFull timeShift workDay shift- ...New Jersey. The role involves supporting regulatory submission activities by performing quality... ...submission documents to ensure compliance with FDA, EU, and internal requirements. The... ...three years of experience in Regulatory Affairs, Document Control, or Quality, coupled...
$61.44k - $84.48k
...determine the current regulatory requirements and strategies... ...documents and/or submissions required to obtain clearance... ...on the corporation. Associate is responsible to... ...the overall Regulatory affairs department growth. Participates... ...skills Knowledge of FDA, EU, MHLW, TGA and...Temporary workWorldwide- ...Regulatory Affairs Associate As a Regulatory Affairs Associate you will: Gain experience and exposure to groundbreaking... ...of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements are desired. Proven leadership capabilities...
- ...Regulatory Affairs Specialist III Location: Bridgewater, NJ Duration: 9 Months Manager will... ...reviewing and processing the regulatory submissions documents including both pre-approval... ...with regulatory communications with the FDA for assigned products and activities, including...Worldwide
- ...according to local language requirements. Review raw materials and associated toxicology/ecotoxicology information to confirm appropriate... ...international chemical inventories and lists for populating regulatory information section of SDS. Maintain transportation (DOT, IATA...Contract workWork at officeLocal areaRemote workShift work
- ...A leading luxury brand is seeking a Customs Compliance Specialist in Piscataway, NJ. This role involves ensuring regulatory compliance across various divisions and requires a minimum of three years of experience in customs compliance. The ideal candidate should possess...Work at officeRemote work3 days per week
$250k
Paramount Residential Mortgage Group Inc. (PRMG Inc.) is hiring for a position focused on residential mortgage financing in Dunellen, NJ. The role includes verifying mortgage application information, advising clients on loan options, and reviewing application files for ...$80k - $96k
...families through our guiding principles. The Regulatory Affairs Specialist is responsible for working... ...will be incorporated into regulatory submissions to assure scientific rigor, accuracy,... ...international and domestic submissions for to FDA, Health Canada and other international...Temporary workWork at officeLocal areaMonday to FridayFlexible hoursShift work- ...A leading regulatory compliance firm is seeking a detail-oriented Regulatory Affairs Associate I to support compliance activities for products distributed in the United States and Canada. The role involves reviewing product formulas and artwork for regulatory compliance...Contract work
$60k - $70k
Overview Responsibilities and duties include reviewing and analyzing system-generated alerts to provide a comprehensive analysis of player transactional activity. This includes reviewing customer profiles, account documentation, prior reviews, past investigations, and ...Shift work$28.36 per hour
...will ensure Berje’s compliance with all Regulatory Standards globally. You will support the preparation, organization, and submission of regulatory documentation related to the... ...Education & Experience:Bachelors Degree and/or Associates with ExperienceMinimum 3-5 years of...Local area$52k - $86k
LIXIL Water Technology Americas in Piscataway Township is looking for a Trade Compliance Post Entry Specialist responsible for managing compliance with U.S. Customs processes. Candidates need 2-4 years of experience and a Bachelor's degree in a relevant field. This fully...Remote work- ...Responsibilities : Excellent employment opportunity for a Regulatory Affairs Specialist II in the Somerville, NJ area. Ensure... ...partners based on factors such as required regulatory submission due dates, time constraints, urgency, and business need....Contract work
- ...Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.... ...manufacturing, and labeling changes. Prepare submissions to U.S., EU, and International health... ...timelines). Prepare 510(k)'s to FDA pertaining to indications for use...Contract workRemote work
- ...Job Title: Regulatory Affairs Specialist Duration: 12 months, potential extension Remote Preferred Ideal Locations: Rochester, NY... ...artwork creation Perform all assigned ELM project tasks Submission artwork support Provides RA artwork support for health...Work at officeRemote workMonday to FridayDay shift
- ...Responsibilities: Excellent employment opportunity for a Regulatory Affairs Specialist in the Raritan, NJ area. Input in... ...Assist in the development of processes related to regulatory submissions Drafts and reviews document content (depending on level...Contract workLocal area
- ...and procedures and understand specific application requirements for both facility credentialing applications and payer enrollment submission. Work collaboratively in a team environment to achieve team and organizational goals by sharing information and resources. May...Work at officeShift work
- ...Township, NJ. The ideal candidate will have at least 3 years of experience in customs compliance and will be involved in facilitating regulatory compliance for various product divisions. This role requires a minimum of three days in-person presence in the office. CHANEL...Remote jobWork at office
$80k - $96k
...Edison, NJ is looking for a dedicated professional to handle FDA regulatory compliance and documentation. In this hybrid role, you will... ...oversee project compliance, and assist teams in regulatory submissions. A Bachelor’s degree in a science-related field and three years...- MTF Biologics is hiring an entry-level Regulatory Affairs Specialist for a hybrid role based in Edison... ...'s degree in science and 3 years of FDA regulated experience. The successful... ...product development processes and coordinate submissions to various regulatory agencies. MTF...Remote job
$80k - $96k
Musculoskeletal Transplant Foundation is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with regulatory requirements... ...knowledge of regulations and assist in documentation for FDA submissions. This hybrid role requires commuting to NJ and Jessup, PA,...$30 - $36 per hour
Job Title: Regulatory Affairs Associate I Position Type: Contract (12+ Months) Location: Clark, NJ 07066 Salary Rate: $30-36/hour Job Description We are seeking a detail-oriented Regulatory Affairs Associate I to support regulatory compliance activities for products distributed...Contract workWork experience placement- brobstongroup.com - Jobboard is seeking a Specialist, Customs Compliance to manage U.S. import/export and customs regulatory compliance in Piscataway, NJ. This hybrid role requires collaboration with legal and supply chain teams, focusing on compliance for fashion and...
$77.4k - $110.3k
Senior Bioanalytical Chemist I, Analytical Chemistry, L’Oréal Research & Innovation We are seeking a Senior Bioanalytical Chemist I to join our Analytical Chemistry team in our state‑of‑the‑art Clark, New Jersey research facility, supporting our Analytical Innovation &...Permanent employmentFull timeWork experience placementSummer workWork at officeFlexible hours$75k - $92k
...Inspector for Woodbridge Township. Candidates must possess a valid elevator inspector license from the NJ Department of Community Affairs and a driver’s license. Experience and additional licensure are advantageous. The salary range for full-time positions is between $...Hourly payFull timePart time
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