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
- Amneal Pharmaceuticals is seeking a Regulatory Affairs Specialist to assist with high-quality regulatory submissions to the FDA, ensuring alignment with timelines and guidelines. The role leads regulatory activity on cross-functional teams across Clinical, CMC, Quality,...Suggested
- 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
- 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
- ...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
- ...Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance... ...skills and 5+ years in pharma regulatory affairs, with 3-4 years in regulatory operations....Suggested
$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: 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...For contractorsLocal area- 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...Long term contract
$86.9k - $121.88k
...right fit for each patient anatomy.The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland... ...reporting process, including data collection, validation, and submission, ensuring timely and compliant reporting in line with TAH...Contract workTemporary workLocal areaImmediate startWorldwideFlexible hours- Breckenridge Pharmaceutical, Inc. in the United States, seeks a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes), support lifecycle management, and assist the Director of Regulatory Affairs. Focus on complex generics...
$75k - $90k
...including documentation screening and review, regulatory data entry in customer file, licensing,... ...of various agencies - DEA, CA DOJ, FDA, OSHA, EPA, DOT, REACH, State Regulatory... ...ERP software Prepare and submit API NDCs submissions Prepare product end-use letters as well...Work experience placementWork at officeLocal areaWork from home$90k - $125k
...from around the world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes... ...and labeling supplements in compliance with FDA requirements. Author relevant eCTD sections...Flexible hours$166.72k - $250.08k
...Job Summary The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic... ...reviewed, and approved in accordance with FDA regulations, guidance, approved... ...and support required promotional submissions, including Form FDA 2253, Subpart E...Work at office$87.58k - $120.42k
...focused culture.About the Role This Senior Associate, Regulatory Affairs role is responsible for independent... ...efficient, compliant execution of submissions, labeling, and maintenance activities... ...experienceStrong understanding of US FDA regulatory frameworksExperience...Full timeWork at office- ...DescriptionResponsibilities:• Author Module 3 submission documentation according to eCTD... ...-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author... ...years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA,...Work at officeLocal areaImmediate start
- ...Opportunity We're looking for a Quality Assurance & Compliance Associate to join our Supply Chain Quality & Production team. This role... ...inspections and in-line quality checks Review test reports, factory submissions, and inspection documents for accuracy Maintain QA/QC logs,...Work at officeWorldwide
$137k - $235.75k
...their merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...for the best talent for an Associate Director, Regulatory Affairs... ...primary point of contact for US FDA. - Lead the regulatory... ...Key contributor to regulatory submission strategy, identifying submission...Full timeLocal areaImmediate startFlexible hours$90k - $144k
...You will support Cyber risk, compliance, regulatory, and operational activities that help... ...visibility to your application status. Current associates who require a workplace accommodation... ...agencies:Fiserv does not accept resume submissions from agencies outside of existing...Full timeTemporary workH1bWork at officeMonday to Friday$60k - $70k
Essential Duties 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 conducting online research...Shift work$80k - $96k
...Regulatory Affairs Specialist MTF Biologics processes tissue grafts from human donors that are... ...that will be incorporated into regulatory submissions to assure scientific rigor, accuracy,... ...and domestic submissions for to FDA, Health Canada and other international...Temporary workWork at officeLocal areaMonday to FridayFlexible hoursShift work- ...OFAC risk. Advise the Bank's Director of Regulatory Compliance, Senior Management, and Bank... ...and measure the BSA/AML and OFAC risks associated with products and services offered by... ...to ensure a complete and accurate MLR submission. Provide guidance and oversight to the...Bank staff
$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,...$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...- ...Training Manager, the Cybersecurity Compliance Specialist is expected to ensure that the institution's operations comply with legal/regulatory standards, and university procedures and policies. Responsibilities Documents and evaluates compliance activities and liaises...
- ...regulations. The role includes documentation review, data entry in customer files, licensing, and reporting to regulatory agencies. The position emphasizes DEA, CA DOJ, FDA, OSHA, EPA, DOT, REACH and state boards familiarity. On-site in New Brunswick, NJ with hybrid...Local area
- Core States Group seeks an experienced Permitting & Regulatory Compliance Specialist II to join our growing team. You will independently... ...with clients, agencies, and internal teams, ensuring timely submissions, regulatory alignment, and proactive communication while...
$29.42 per hour
Overview The Fountain Group is currently seeking a Regulatory Affairs Associate I for a prominent client of ours. This position is located at Clark, NJ. Pay Rate: $29.42/Hour Duration: 6 months Shift Details: Hybrid is dependent upon candidate engagement, reactivity...Shift work- ...expertise in customs clearance processes, trade documentation, and cross-functional coordination to drive operational efficiency and regulatory compliance across the organization.Essential Responsibilities:Serve as the primary SME for U.S. and international import/...Full timeWork at office
$166k - $203k
...Position Summary The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability... ...for leading interactions with the FDA Office of Prescription Drug... ...individual will be responsible for all submission types made to OPDP/APLB (FDA). The...Work at officeLocal areaWorldwide- East Brunswick Township is accepting applications for a Plumbing Inspector (I.C.S or H.H.S.) to join the Division of Construction Inspection. The role involves inspecting building work on new and existing commercial, industrial, and residential structures to ensure compliance...Full timePart timeFlexible hours
- Are you a credentialed life insurance producer who feels constrained by corporate caps, captive carrier limitations, or opaque lead structures? We are expanding our network of established financial protection specialists. This 1099 entrepreneurial partnership is tailored...Contract workWork at officeImmediate startRemote work
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