1,571 Results for

Regulatory Affairs Jobs in Cooper, NY

Jobs

Executive Medical Director, Clinical Development - M.D. (Nephrology) Top Echelon

Jersey City, NJ

Quick Apply

The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.

3 days ago

Pharmaceutical Territory Sales Specialist Inizio Engage

Edison, NJ

$60,000–$110,000 / year

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. As part of our commitment to a fair and equitable hiring process, candidates are expected to complete all interview activities without the use of artificial intelligence tools or external assistance unless such assistance is authorized in advance by Inizio Engage or otherwise required in accordance with applicable law.

4 days ago

Regulatory Affairs Senior Manager, Regulatory Information & Content Management Becton Dickinson and Co

Franklin Lakes, NJ

$172,000–$275,200 / year

Primary Responsibilities: Lead Global Regulatory Information and Content Management: Provide strategic and operational leadership for global regulatory information, regulatory content, digital capabilities supporting document and submission management, and assigned digital platforms, ensuring alignment with regulatory strategy, business needs, and the broader Digital RA roadmap. The Senior Manager, Regulatory Information & Content Management is responsible for developing, executing, and maintaining the global Regulatory Affairs strategy and roadmap for regulatory information, regulatory content, and the digital platforms that support their management across Business Units and Regions, in alignment with the broader Digital RA strategy and with specific responsibility for the Regulatory Information Management System (RIM).

16 days ago

Regulatory Affairs Associate I IntelliPro Group Inc.

Clark, NJ

$30–$36 / hour

This role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.

30+ days ago

Regulatory Affairs Specialist Nesco Resource, LLC

Melville, NY

$105,000–$115,000 / year
Quick Apply

Very well-established and highly successful domestic and international medical device manufacturer has an exciting career opportunity for a highly talented and well-experienced Regulatory Affairs Specialist with FDA experience who will report directly into the Regulatory Affairs Manager. Communicate the requirements for 510K submittal to appropriate cross functional teams to help facilitate continuous internal process improvement activities assuring compliance to regulatory requirements (i.e. GMP principles, SOP's).

17 days ago

Senior Manager, Regulatory Affairs, CMC Shionogi Inc.

Florham Park, New Jersey

$140,000–$170,000 / year

Demonstrated ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to achieve regulatory milestones and drive product development initiatives forward. Work closely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines.

30+ days ago

Senior Manager, Regulatory Affairs, CMC Shionogi & Co Ltd

Florham Park, NJ

$140,000–$170,000 / year

30+ days ago

Senior Specialist, Regulatory Affairs ImmunityBio

Summit, NJ

Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

30+ days ago

Associate Director, Regulatory Affairs - CMC BridgeBio Pharma Inc

$190,000–$285,000 / year

In conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.

30+ days ago

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory FirstEnergy Corp

Holmdel, NJ

$157,590–$222,480 / year

Given the complexity of New Jersey''s regulatory environment, the frequency and significance of ongoing regulatory proceedings, and the need to protect both customer and shareholder interests, backfilling this position is necessary to maintain continuity of expertise, preserve key stakeholder relationships, support critical business initiatives, and ensure successful execution of JCP&L''s regulatory and financial objectives. We are committed to rewarding individual and team efforts through our total rewards philosophy which includes competitive pay plus incentive compensation, a company-sponsored pension plan, 401 (k) savings plan with matching employer contribution, a choice of medical, prescription drug, dental, vision, and life insurance programs, as well as skills development training with tuition reimbursement.

19 days ago

Regulatory Affairs Specialist OrganOx

Madison, NJ

$120,000–$135,000 / year
Quick Apply

The role works closely with Regulatory Affairs team members responsible for software, hardware, disposable products, labelling, and other regulatory disciplines to support submission activities, maintain accurate regulatory records, and ensure alignment across product areas and markets. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.

30+ days ago

Sr. Regulatory Affairs Specialist VB Spine LLC

Allendale, NJ

$100,000–$105,000 / year

As a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.

30+ days ago

Director, Regulatory Affairs Eikon Therapeutics Inc

Jersey City, NJ

$213,000–$232,750 / year

This role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

30+ days ago

Associate Director, Regulatory Affairs Legend Biotech US

Somerset, New Jersey

Serves as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.

28 days ago

Associate Director, Regulatory Affairs Legend Biotech Corp

Somerset, NJ

$168,372–$220,988 / year

27 days ago

Regulatory Affairs Strategist, Digitalization - Advertising & Promotion Becton Dickinson and Co

Franklin Lakes, NJ

$135,500–$216,800 / year

Manage Platform Roadmap and Continuous Improvement: Manage the business platform roadmap by identifying, evaluating, prioritizing, and advancing platform capabilities and improvements, including opportunities related to workflow, AI-enabled capabilities, automation, reporting, integration, data quality, and user experience, in alignment with the broader Regulatory Affairs digital roadmap. Manage Global Ad/Promo Digital Platforms: Serve as the Regulatory Affairs business owner for digital platforms supporting Advertising & Promotion, providing business leadership for platform operations, lifecycle management, enhancements, releases, and continuous improvement.

30+ days ago

Manager - Quality & Regulatory Affairs Envista

Mahwah, NJ

Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.

30+ days ago

Manager - Quality & Regulatory Affairs Envista Holdings Corp

Mahwah, NJ

30+ days ago

Manager Regulatory Affairs, Advertising & Promotion (Remote) Regeneron Pharmaceuticals Inc

Remote

$128,600–$210,000 / year

Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

9 days ago

Staff Regulatory Affairs Specialist - Pharma Becton Dickinson and Co

Franklin Lakes, NJ

$117,800–$188,600 / year

Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner, to manage multiple projects/tasks simultaneously, and effectively manage and prioritize regulatory submission projects. Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.

26 days ago

See More Jobs

Browse All Regulatory Affairs Locations

Browse Jobs Near Cooper, NY

Get noticed by top employers!

Upload your resume to let employers know you're open to Regulatory Affairs job opportunities. Plus, receive relevant job recommendations in your inbox.

Create A Free Account

Regulatory Affairs Jobs in Cooper, NY

Executive Medical Director, Clinical Development - M.D. (Nephrology) Top Echelon

Pharmaceutical Territory Sales Specialist Inizio Engage

Regulatory Affairs Senior Manager, Regulatory Information & Content Management Becton Dickinson and Co

Regulatory Affairs Associate I IntelliPro Group Inc.

Regulatory Affairs Specialist Nesco Resource, LLC

Senior Manager, Regulatory Affairs, CMC Shionogi Inc.

Senior Manager, Regulatory Affairs, CMC Shionogi & Co Ltd

Senior Specialist, Regulatory Affairs ImmunityBio

Associate Director, Regulatory Affairs - CMC BridgeBio Pharma Inc

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory FirstEnergy Corp

Regulatory Affairs Specialist OrganOx

Sr. Regulatory Affairs Specialist VB Spine LLC

Director, Regulatory Affairs Eikon Therapeutics Inc

Associate Director, Regulatory Affairs Legend Biotech US

Associate Director, Regulatory Affairs Legend Biotech Corp

Regulatory Affairs Strategist, Digitalization - Advertising & Promotion Becton Dickinson and Co

Manager - Quality & Regulatory Affairs Envista

Manager - Quality & Regulatory Affairs Envista Holdings Corp

Manager Regulatory Affairs, Advertising & Promotion (Remote) Regeneron Pharmaceuticals Inc

Staff Regulatory Affairs Specialist - Pharma Becton Dickinson and Co

Similar Job Searches

See More Jobs