Regulatory affairs jobs in New York, NY - Page 3Create job alerts

Responsibilities: The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices. This role involves ensuring compliance with global regulations, preparing and managing regulatory submissions, and acting as a l...

Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business System Management. Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovati...

Associate Director, Regulatory Affairs. We are seeking an experienced Senior Manager to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this role, they will excel in developing and executing global CTA submission strat...

Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development.Assures that defined regulatory strategies are effectively implemente...

Collaborates with Nursing Leadership and Regulatory Affairs Leadership to develop and improve departmental, interdisciplinary, and service structure standards. Serves as a liaison between the leadership on premises and the administrator-on-call, Office of Public Affairs, Chief Medical Officer and...

Associate Director, IT R&D Operations.The call to action to extend and improve the lives of cancer patients is louder than ever before, and Syndax is seeking individuals who are committed to science, innovation and excellence to join us on this mission.With offices in NYC and experts employed aro...

Ensure regulatory strategic options, assessments, and risks are communicated to regulatory management and project team. Provide regulatory leadership by developing, driving, and implementing regulatory strategies for assigned products. Ensure regulatory management is informed of key regulatory ac...

Staff Regulatory Affairs Specialist. The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of glob...

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team.When you join ADC Therapeutics, you will join a group of talented people who share this mission.ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug con...

Vice President Regulatory Group.We are seeking a seasoned professional to join our Regulatory Group as a Vice President, with a primary focus on managing regulatory exams.This role is part of the Firm's Legal Department and plays a key role in ensuring regulatory compliance and oversight.While a ...

Interact with regulatory agencies (SEC, CFTC, NFA, OCC, etc. Ideally experience with Investment Advisors/RIA from a regulatory perspective. Develop and maintain regulatory submission strategies, ensuring timely and accurate submissions.

Senior Counsel, Assistant Vice President of Legal Affairs, Grants, Funding & Regulatory Compliance. Senior Counsel, Assistant Vice President of Legal Affairs, Grants, Funding & Regulatory Compliance. RWJBarnabas Health, New Jersey s largest integrated academic healthcare system, seeks a high

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 ...

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Company's quality, preclinical, and clinical drug development programs, policies, and procedures, so that development teams are a...

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...

Responsibilities: Leading/coordinating execution of CMC regulatory filing strategy and managing or supporting regulatory processes to achieve timely approval. Preparing high quality CMC regulatory documents or packages in accordance with company standards and procedures, ensuring thoroughness, ac...

Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement. Community Finance builds inclusive, thriving resident-centered communities that...

Strong understanding and direct relevant experience with the Data Strategy and Management landscape of pharmaceutical regulatory affairs and Regulatory Information Management. The Capability Lead will drive the Centralized Data Quality Management culture in Regulatory Affairs and ensure Data Qual...

Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Leadership Role For Global Regulatory Strategy. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests...

The Capability Lead will drive the Centralized Data Quality Management culture in Regulatory Affairs and ensure Data Quality consistency, correctness and completeness across all applicable RA systems and platforms. Data Governance And Quality Capability Lead. The Data Governance and Quality Capab...

Malin+Goetz is looking for a Senior Manager of Regulatory Affairs to support all professional and consumer businesses of the Company and international developments. Malin+Goetz Senior Manager Of Regulatory Affairs. Malin+Goetz is seeking a Senior Manager of Regulatory Affairs to drive global comp...

Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well. Responsibilities: This position is responsible for...

Strong understanding and direct relevant experience with the Business Architecture and Data Integrations landscape of pharmaceutical regulatory affairs and Regulatory Information Management. As a member of the Regulatory Affairs Data Strategy and Management Platform, the Business Architecture & D...

Regulatory Affairs Specialist Immigration Law. Required: Master in Law & 6-month law firm experience to perform compliance research and regulatory analysis.

Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions. Coordinate with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development and Regulatory Stra...

Strong understanding and direct relevant experience with the Business Architecture and Data Integrations landscape of pharmaceutical regulatory affairs and Regulatory Information Management. This role requires a deep understanding of regulatory data and how it flows through systems across the reg...

Top 3-5 skills you are looking for: Advanced degree experience in medical and/or regulatory affairs clinical background strong organizational and communication skills.This position reports to the Myeloid Medical Promotional Review lead and is a key member of the US Medical Affairs Myeloid Team.Th...

Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions.Assisting in preparing presentations, reports, and strategic documents for leadership discussions.Maintaining and tracking project timel...

Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling projects in close collaboration with GLM/GL-TAL. Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory su...

As the Senior Global Program Clinical Head (GPCH), you are the clinical lead and will serve as a key member of the Global Program Team, contributing to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs, Market Access and others. Senior Global Program C...

The above reflects the anticipated annual salary range for this position if hired to work in New Jersey.The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience.Senior C...

Strong collaboration skills to work effectively with cross-functional teams, including marketing, legal, medical affairs, and regulatory teams, ensuring regulatory considerations are integrated into promotional strategies. Proactively remains informed about regulatory trends, changes, and emergin...

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...

Senior Manager, Us Medical Myeloid, Aml & Mf 100% On-site.At client, we are inspired by a single vision transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passi...

Adaptability, Adaptability, Business Processes, Change Management, Communication, Cross-Cultural Awareness, Data Management, Drug Development, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Process Improvements, Project Information Manag...

Responsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Respon...

Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.

Under the direction of the Director, Medical and Regulatory Affairs, is responsible for working with key stakeholders to execute the medical affairs plan, including post-marketing research, congress management, medical education, research grants, medical advisory boards, and scientific communicat...

Job Description At Oura, our mission is to empower every person to own their inner potential. With our award-winning Oura Ring and app, we help over 2.5 million people turn insights about sleep, activity, and readiness into healthier, more balanced lives. We believe that starts from within — by c...

Job DescriptionAbout New York Edge New York Edge (NYE) is the largest provider of school-based afterschool and summer programming in New York City, serving thousands of students annually across all five boroughs and Long Island. Our mission is to help young people discover their potential by prov...

The Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance reports directly to the Vice President of Legal Affairs. Senior Counsel, Assistant Vice President of Legal Affairs, Clinical Research & Regulatory Compliance. Counsel stakeholders on Good Clin...

Eligibilities & qualifications.

About the Team The Medical and Scientific Affairs, Core Lab, Regulatory and AI/Innovative Product Affairs teams share dedication and passion to release innovative products that will guide physicians to lower the number of heart attacks in their patients by providing a personalized assessment of r...

BS in Nutrition Science, Food Science, Engineering or equivalent as minimum. This position will interact with the greater Global Regulatory Affairs organization as well as many other functions, including but not limited to Product Development, Food Safety & Quality Assurance, Systems & Administra...

Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts. Develop and maintain standard operating procedures, work instructions, and polic...

Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for ANDA’s. Bachelor’s degree with 8 plus years’ experience in regulatory strategy and filing of ANDA’s, in a pharmaceutical Industry.

Job Description Job Title: Assistant Manager, Campaign Department: Health Fund Admin Reports To: Manager, Campaign FLSA Status: Exempt, Management Created: 7/1/2025 Overview of the Health Fund: The 32BJ Health Fund is a multiemployer labor-management fund that provides health ben...

Job DescriptionSalary: $85K to $110K About the Organization We are active in venture capital, opportunistic real estate and family office activities. Check out . Executive Assistant We are seeking a highly organized, discreet, and proactive Executive Assistant ...