1,608 Results for

Regulatory Affairs Jobs in South Pole, NY

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Sr. Director, Regulatory Affairs Eikon Therapeutics Inc

Jersey City, NJ

$235,000–$288,750 / year

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. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

30+ days ago

Sr. Manager, Regulatory Affairs Colgate-Palmolive Co

Piscataway, NJ

$139,200–$174,000 / year

Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses - Oral Care, Personal Care, Home Care and Pet Nutrition.

5 days ago

Senior Regulatory Affairs Specialist - Software OrganOx

Madison, NJ

$115,000–$140,000 / year
Quick Apply

Under direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

30+ days ago

Head of Regulatory Affairs Brex Inc

New York, NY

Remote

$270,000–$335,000 / year

By combining global corporate cards and banking with intuitive spend management, bill pay, and travel software, Brex enables founders and finance teams to accelerate operations, gain real-time visibility, and control spend effortlessly. You will run the end-to-end regulatory engagement lifecycle: exam preparation and logistics, fulfillment of supervisory requests, coordination of responses across Legal, Compliance, Risk, and business teams, and disciplined tracking of findings, commitments, and corrective actions through to closure.

30+ days ago

Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals

Tarrytown, NY

$109,900–$179,300 / year

Discover your role: Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

30+ days ago

Senior Associate, Regulatory Affairs Submission Management - Hybrid AbbVie, Inc

Florham Park, NJ

With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. Responsibilities: Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.

18 days ago

Senior Associate Regulatory Affairs Submission Management - Hybrid AbbVie Inc

Florham Park, NJ

18 days ago

Senior Manager, Regulatory Affairs BeOne Medicines AG

$139,800–$184,800 / year

The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions. Essential Functions of the Job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.

30+ days ago

Regulatory Affairs Analyst Adults and Children with Learning and Disabilities Inc

Bethpage, NY

Provide expert technical and consulting support, regarding OPWDD regulations, ACLD policies and procedures in regulatory affairs related programs and other complex related matters to the ACLD workforce. Assist in the training of all new management level staff to ensure consistency in training and orientation of new managers and administrators within assigned programs, i.e., personal needs allowance, etc.

30+ days ago

Senior International Regulatory Affairs Specialist BD (Becton, Dickinson and Company)

Franklin Lakes, NJ

$110,200–$176,400 / year

Proactively identifies regulatory risks, assesses potential business impact, develops mitigation plans, and escalates critical issues in a timely manner to enable effective decision-making and maintain project timelines. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

7 days ago

Regulatory Affairs Project Manager Colgate-Palmolive Co

Piscataway, NJ

$124,000–$155,000 / year

10 days ago

Senior Manager Regulatory Affairs Global Reg Strategy US & Canada AbbVie Inc

Florham Park, NJ

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

30+ days ago

Sr. Director, Regulatory Affairs Eikon Therapeutics, Inc.

Jersey City, NJ

$235,000–$288,750 / year

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.

30+ days ago

Regulatory Affairs Strategist, Globalization (Americas - US, Canada, LATAM) Becton Dickinson and Co

Franklin Lakes, NJ

$135,500–$216,800 / year

The Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.

30+ days ago

Regulatory Affairs Strategist, Globalization (Americas - US, Canada, Latam) BD (Becton, Dickinson and Company)

Franklin Lakes, NJ

$135,500–$216,800 / year

7 days ago

Principal Scientist, CMC Regulatory Affairs - Medical Devices & Combination Products Organon & Co

Florham Park, NJ

$168,000–$285,800 / year

The Principal Scientist, CMC Regulatory Affairs - Medical Devices & Combination Products provides strategic leadership and execution for global regulatory activities supporting medical devices, drug-device combination products, and associated CMC regulatory programs across development, registration, commercialization, and lifecycle management. The Director reports to the Executive Director, and partners closely with Product Development, Device Engineering, Pharmaceutical Development, Quality, Manufacturing, Supply Chain, Clinical, Safety, Commercial, and Global Regulatory Affairs organizations to navigate complex and evolving regulatory requirements while advancing innovative products through the global regulatory landscape.

5 days ago

Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals

Tarrytown, NY

$128,600–$210,000 / year

Discover your role: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

30+ days ago

Regulatory Affairs Specialist Hartz

Secaucus, NJ

$58,000–$72,000 / year

File new product registrations and approvals for EPA products across all 50 U.S. states and Puerto Rico, including submission tracking and follow-up on pending approvals. While working closely with the Manager of Regulatory Affairs, you will coordinate pesticide registrations, prepare and track regulatory submissions and amendments, and support applications through approval.

11 days ago

Sr. Specialist, Regulatory Affairs Metagenics

Jersey City, New Jersey, United States, New Jersey

Monitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.

30+ days ago

Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations) Becton Dickinson and Co

Franklin Lakes, NJ

$137,500–$220,100 / year

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. Job Summary: The Regulatory Affairs Strategist, Globalization is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams.

16 days ago

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Regulatory Affairs Jobs in South Pole, NY

Sr. Director, Regulatory Affairs Eikon Therapeutics Inc

Sr. Manager, Regulatory Affairs Colgate-Palmolive Co

Senior Regulatory Affairs Specialist - Software OrganOx

Head of Regulatory Affairs Brex Inc

Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals

Senior Associate, Regulatory Affairs Submission Management - Hybrid AbbVie, Inc

Senior Associate Regulatory Affairs Submission Management - Hybrid AbbVie Inc

Senior Manager, Regulatory Affairs BeOne Medicines AG

Regulatory Affairs Analyst Adults and Children with Learning and Disabilities Inc

Senior International Regulatory Affairs Specialist BD (Becton, Dickinson and Company)

Regulatory Affairs Project Manager Colgate-Palmolive Co

Senior Manager Regulatory Affairs Global Reg Strategy US & Canada AbbVie Inc

Sr. Director, Regulatory Affairs Eikon Therapeutics, Inc.

Regulatory Affairs Strategist, Globalization (Americas - US, Canada, LATAM) Becton Dickinson and Co

Regulatory Affairs Strategist, Globalization (Americas - US, Canada, Latam) BD (Becton, Dickinson and Company)

Principal Scientist, CMC Regulatory Affairs - Medical Devices & Combination Products Organon & Co

Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals

Regulatory Affairs Specialist Hartz

Sr. Specialist, Regulatory Affairs Metagenics

Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations) Becton Dickinson and Co

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