Fda regulatory jobs in New York, NY - Page 3Create job alerts

Job DescriptionSkills: GCP Sr. Auditor, GCP, Auditor, Pharmaceutical, Audits, SOPs, QMS, GXP QA audit programs, GXP Compliance, GXP, Clinical Vendor Audits, SMEs (IRT, EDC etc.), FDA regs, Regulations, Biopharmaceutical, Safety Pharmacovigilance, Clinical Development& JOB DESCRIPTION: • The GC...

Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection)...

Job Description Job Title: Quality Control Manager / SQF Practitioner Location: Paterson, NJ Type: Full-Time | On-Site About the Role: We’re looking for a passionate, hands-on Quality Control Manager with SQF Practitioner certification to lead all quality assurance and food safety efforts at ...

Job Description Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is a...

Job Description Children’s Tumor Foundation Job Description The Chief Scientific Officer is a key member of the Executive Leadership team and oversees the strategy, research, and programs of the Science and Education team to advance research, treatment, and advocacy for those affected ...

Job DescriptionAbout Weee! Weee! is the largest and fastest-growing ethnic e-grocer in the United States, operating in one of the largest underserved categories in retail with affordable access to exciting ethnic food. By partnering with local suppliers, redesigning the value chain and leveraging...

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of...

Job Title: Product Validation Consultant Start Date: ASAP Duration: 3 months + opportunity to extend Logistics: Primarily onsite, could taper to hybrid later in project Hours/week: 40 to start. Most likely for first 3 months. Depending on project needs and extension, could taper down to ...

Responsibilities • Analyze and interpret complex datasets to support regulatory reporting, clinical operations, and supply chain optimization, • Collaborate with cross-functional teams to gather requirements and develop dashboards, reports, and data models using BI tools, • Ensure data integri...

Take your career to the next level with the best in the business. New Hyde Park, NY (On-site) Accelerated Global Solutions (AGS) is more than a logistics provider — we're a launchpad for driven professionals who want to learn, grow, and succeed alongside industry leaders. As a Customs En...

The Opportunity: A highly ranked and leading global pharmaceutical company located in New Jersey seeks an Associate Senior Counsel - Market Access to join their legal team. This position is hybrid in Essex County with a compensation package between $236K - $248K, plus bonus, LTI and a competiti...

Clinical Scientist (Manager/Senior Manager), Oncology Location: New York, NY - This role is hybrid onsite. Candidates must be open to relocating to NYC or be able to commute into the city 2-3 times per week. Scientific Search has recently partnered with a clinical-stage pharmaceutical company ...

Mama’s Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Company’s broad product portfolio, born as MamaMancini’s, from a rich history in Italian foods, now consists o...

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for...

Hours are 3-11:30 pm. The 2nd Shift Sanitation Manager is responsible for overseeing and leading the sanitation team to ensure all equipment, machinery, and facility areas are cleaned and sanitized according to company policies, food safety standards, and regulatory requirements. This role pl...

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Ma...

About this role: The primary accountability of this role is to ensure client success by leading, planning, and executing a broad portfolio of development projects. This includes oversight of formulation and process development activities from pre-formulation through clinical batch production and...

Overview: We are seeking a highly organized and results-driven Program Manager to lead and coordinate cross-functional activities related to combination product development. This role is responsible for overseeing program deliverables, ensuring timely reporting, and driving alignment across engi...

Job Title: Product Validation Consultant Start Date: ASAP Duration: 3 months + opportunity to extend Logistics: Primarily onsite, could taper to hybrid later in project Hours/week: 40 to start. Most likely for first 3 months. Depending on project needs and extension, could taper down to l...

Job DescriptionSUMAMRYThe Packer is responsible for accuracy of bag weights, sealing and labeling of bags, coding of bags, checking to be sure the correct bags are being packed, and ensuring volume of output. They are also responsible for keeping the work area neat and clean. Packers may be assig...

Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions. As a Regulatory Affairs Lead, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized in the smart wearables ...

Responsibilities: Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.Execute commissioning and qualification activities for utilities systems, ensuring adherence to p...

Responsibilities: Prepare, review, and submit regulatory documents to FDA. Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals. Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standard...

Responsible for ensuring that products made in the facility are produced in accordance with the HACCP plan and comply with both FDA and USDA regulatory standards, as well as customers' requirements.Assist the Quality Manager in driving a food safety culture and continuous improvement strategies.E...

Strong knowledge and experience with regulatory affairs and FDA regulations, with knowledge of other key regions including EU and other international regulatory affairs (e. The VP of Global Regulatory Affairs provides the strategic and operational leadership and management of the regulatory funct...

Extensive experience in the pharmaceutical industry with at least 10+ years' experience in a regulatory affairs. Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and Corresponding Acknowledg...

Strong knowledge and experience with regulatory affairs and FDA regulations, with knowledge of other key regions including EU and other international regulatory affairs (e. The VP of Global Regulatory Affairs provides the strategic and operational leadership and management of the regulatory funct...

Job DescriptionOur mission: to eliminate every barrier to mental health. At Spring Health, we're on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need, when they need it. Our clinically validated technology, Precision Menta...

Job Description Oncology Research Project Manager Are you a strategic leader with a passion for driving oncology research forward? Do you thrive when mentoring teams, managing complex clinical trials, and delivering results in a fast-paced environment? Do you see opportunity in innovation and sa...

Job Description About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a ...

Job Description Solutions Architect / Technical Estimator – MedTech Innovation (Newark, NJ) Are you an engineering powerhouse with a knack for crafting complex solutions and a passion for precision manufacturing in the medical device industry? Our client, an internationally recognized leader...

Job Description WSAudiology is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum ...

Job Description SUMMARY This position is responsible for working directly with Operations, Customer Service, Inside Sales and Transportation on a daily basis. They analyze and organize office operations and procedures such as invoicing, data entry, order taking, order entry, book keeping, flow o...

Job Description Human Factor Lead Type: Part-Time Hours Per Week: 25 hours + (Could be more) Note: For the right candidate the goal is to convert Number of Positions: 1 Work Style: Remote Hours in Work Week: EST Targeted Start Date: Monday, June 2nd Estimated End Date: End of September 2025 Expen...

Job Description Job Title: Rare Disease Account Manager, Metabolic (Hartford, CT, New York, NY and Newark, Job Location: New York, NY, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level With its beginnings in a family run pharmacy in Correggio, I...