FDA Submissions Lead - Regulatory Affairs Specialist
RXinsider LTD.
Amneal Pharmaceuticals in Piscataway, NJ, seeks a Regulatory Affairs Specialist to lead and support high-quality regulatory submissions to the FDA, including NDA, IND, BLA, PADERs, and post-approval reports. The role collaborates with Clinical, CMC, Quality, and Marketing to meet timelines. Requirements include a Bachelor’s degree in Pharmacy Administration, Chemistry, Pharmaceutical Manufacturing, or related field, and at least 5 years in a regulatory role. #J-18808-Ljbffr RXinsider LTD.
$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with... ...of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines... ...serves as regulatory lead on cross functional teams including...SuggestedFor contractorsLocal area- 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
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- ...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. Competitive...Suggested
$137k - $235.75k
...and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... ...Serve as primary point of contact for US FDA.Lead the regulatory response team for FDA and... ....Key contributor to regulatory submission strategy, identifying submission risks...SuggestedFull timeLocal areaImmediate startFlexible hours- ...Regulatory Affairs Specialist III Location: Bridgewater, NJ Duration: 9 Months Manager will consider... ...and processing the regulatory submissions documents including both pre-approval... ...with regulatory communications with the FDA for assigned products and activities,...Worldwide
- ...Talent. Job Description Description: The Regulatory Affairs Associate, with minimal guidance... ...submits high quality annual reports with FDA within Annual report timelines and in accordance... ...obtaining documents for annual report submissions. Archive and maintain all post...
- ...DescriptionResponsibilities:• Author Module 3 submission documentation according to eCTD... ...external cross-functional project teams.• The Regulatory CMC Technical Associate may be called... ...• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA...Work at officeLocal areaImmediate start
$86.9k - $121.88k
...time with or without notice.The Senior Healthcare Compliance Specialist supports the development, implementation, and continuous improvement... ...reporting process, including data collection, validation, and submission, ensuring timely and compliant reporting in line with TAH...Contract workTemporary workLocal areaImmediate startWorldwideFlexible hours$100k - $110k
...customers across over 100 countries and regions.Job Title: Procurement Lead, Direct MaterialsLocation: Piscataway, NJ (4 Days onsite with... ...to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements.The ideal candidate...Long term contractTemporary workRemote workFlexible hours$109.6k - $137k
...goals. Together, let's build a brighter, healthier future for all.Join a global supply chain powerhouse as our Distribution Strategy Lead ready to step directly into the center hub of our logistics operations. As our Distribution Strategy Lead, you will have a direct...Hourly payContract workLocal areaRelocation- ...0182Reference26-01179Remote50% RemoteSummary: Our client is a leading medical device company and is seeking an experienced CAPA Program... ...quality remediation initiative supporting medical device regulatory compliance. This consultant will assess existing quality processes...
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$80k - $96k
Musculoskeletal Transplant Foundation is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with regulatory requirements... ...of regulations and assist in documentation for FDA submissions. This hybrid role requires commuting to NJ and Jessup, PA...$80k - $96k
...through our guiding principles. The Regulatory Affairs Specialist is responsible for working with product... ...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$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...$115.2k - $174k
...Analytics within our Global Information Technology’s Global Application and America’s Marketing Team. Operating within the world’s leading Oral Care Company, we are leveraging some of the leading cloud based marketing technology to digitally connect. You will be responsible...Hourly payLocal areaRelocation$109.6k - $155k
...healthier future for all.As our Procurement Innovation & Integration Lead you will be the strategic architect of our North American... ...to Environmental Occupational Health and Safety, Quality, and Regulatory compliance standardsOversee critical supplier management, including...Hourly payLocal areaRelocation package- Role: Regulatory Affairs Associate Location: United States Duration: Long Term contract Position... ...will assist in preparing regulatory submissions, maintaining regulatory documentation,... ...product registrations to ensure adherence to FDA and global regulatory standards. Key...Long term contract
$166.72k - $250.08k
...Job Summary The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides... ..., and approved in accordance with FDA regulations, guidance, approved labeling... ...Guide and support required promotional submissions, including Form FDA 2253, Subpart E/H,...Work at office- SERVPRO of Piscataway is seeking a Restoration Supervisor to oversee and lead our restoration technicians. You will coordinate, monitor, and perform work activities on projects to fulfill service needs and deliver a positive customer experience. The role requires a self...
- ...entrepreneurial mindset. Role Description: dThe Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure... ...filings with agencies such as the U.S. FDA, European Notified Bodies, and other...InternshipWork at officeWorldwide
- ...Description: We are seeking an experienced and motivated Inventory Control Team Lead to oversee inventory operations within our warehouse and manufacturing environment. This role is responsible for maintaining accurate inventory levels, investigating discrepancies...Hourly payShift work
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$23 - $28.75 per hour
...purchase shares of BJ’s common stock at a 15% discount.* *Eligibility requirements vary by position. Job Summary The Meat Lead is responsible for overseeing meat department operations, ensuring compliance with food safety standards, maintaining inventory and...Weekly payFull timeSeasonal workFlexible hours- ...Opportunity for advancement Paid time off Training & development About Role: We are seeking a highly experienced Gen AI Platform Lead with deep expertise in Agentic AI development, autonomous AI systems, multi-agent orchestration, LLM infrastructure, voice AI,...Full time
$70k - $100k
...agreeable to you. Overview We are seeking a Document Control Lead to support a Client’s portfolio of capital projects within an... ...Perform quality checks to ensure documentation meets project, regulatory, and company standards. Generate document control reports...Full timeContract workTemporary workFor contractorsWork at officeImmediate start$131k - $210k
...research and manufacturing facilities. We are looking for a dedicated Lead Architect to join our talented team at our office in Somerset,... ...and/or assigned group staff to assure compliance with legal, regulatory, and IPS project requirements. Protects IPS corporate...For contractorsWork at officeFlexible hours- ...cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and... ...development), labeling updates for marketed products, generation of FDA meeting requests and corresponding briefing materials, and...Work at officeImmediate start
$21.12 - $30.1 per hour
...Lead Technician Req #: 0000252307 Category: Telemetry Nursing Status: Full-Time Shift: Night Facility: RWJ New Brunswick Department: Telemetry Services Pay Range: $21.12 - $30.10 per hour Location: One Robert Wood Johnson...Hourly payFull timeTemporary workWork experience placementLocal areaFlexible hoursShift workNight shift
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