162 Results for

Regulatory Affairs Jobs in New Haven, CT

Jobs

Vice President, Regulatory Affairs The Cooper Companies Inc

Trumbull, CT

$220,000–$350,000 / year

This position collaborates extensively with Research & Development, Clinical Affairs, Quality, Medical Affairs, Manufacturing, Supply Chain, Legal, Marketing, Commercial, and Product Management organizations to support the successful development, approval, commercialization, and lifecycle management of the Company''s products globally. The Global Head of Regulatory Affairs provides leadership for all regulatory activities worldwide and is accountable for building a high-performing organization that delivers predictable regulatory outcomes, proactively manages risk, and drives competitive advantage through regulatory strategy.

17 days ago

Senior Regulatory Affairs Specialist Yale University

Connecticut

Reporting to the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist independently leads regulatory activities for Yale Cancer Center Clinical Trials Office clinical research protocols from study activation through closeout while managing the study portfolio for assigned disease teams. In addition, the Senior Regulatory Affairs Specialist mentors and provides guidance to Regulatory Affairs Specialists I and II, promotes best practices, and identifies opportunities to improve regulatory processes and operational efficiency in support of disease program and departmental objectives.

2 days ago

Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer Ingelheim

Ridgefield, CT

$170,000–$269,000 / year

If you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.

30+ days ago

Regulatory Affairs Analyst Yale University

New Haven, CT

$55,000–$85,000 / year

Activities supported by regulatory affairs include, but may not be limited to: preparation and submission of initial protocol, amendment, and continuing review submissions to the Protocol Review Committee, IRB, and ancillary committees; tracking evidence of protocol and IRB-required training for all research staff; maintenance and sharing of regulatory files with study sponsor monitors, auditors and inspectors to ensure compliance with protocol requirements, university and applicable authorities; receipt and tracking of safety reports; collaborating with CTO staff, laboratory and pharmacy staff regarding study status changes; and serving as a liaison between the CTO, research staff and study sponsor when communicating regulatory matters. Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters.

5 days ago

Assistant Director, Regulatory Affairs Yale University

New Haven, CT

$105,000–$174,000 / year

Reporting directly to the Yale Cancer Center (YCC) Clinical Trials Office (CTO) Director of Operations, the Assistant Director, Regulatory Affairs acts as sole leader of the Clinical Trials Office regulatory division, overseeing the central regulatory teams Regulatory Managers, Regulatory Affairs Specialists, and Regulatory Research Assistants. Manages and directs the ongoing and day to day operations of the assigned disease team portfolio staff, consisting of Senior Regulatory Project Managers, Regulatory Project Managers, Regulatory Managers, Regulatory Assistants, and Research Assistants in Regulatory Affairs.

30+ days ago

Director Quality Systems & Regulatory Affairs Remote - East Coast Cefaly Technology sprl

Darien, CT

Remote

$160,000–$180,000 / year

A critical priority for this role will be optimizing and expanding the company's electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This role is being added to strengthen organizational quality and regulatory capabilities, reduce single-point dependency risk, improve QMS sustainability, and establish scalable systems supporting long-term growth and compliance excellence.

30+ days ago

Regulatory Affairs Specialist Globalchannelmanagement

Trumbull, Connecticut

Strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Regulatory Affairs Specialist requires: 1-3 years experience in regulatory affairs field of Laundry and detergents or CPG products.

30+ days ago

Post-Doctoral Regulatory Affairs Fellow - Advertising and Promotion Boehringer Ingelheim International GmbH

Ridgefield, CT

The Regulatory Affairs Fellow - Advertising and Promotion is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory.

30+ days ago

Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer Ingelheim

Ridgefield, CT

$250,000–$394,000 / year

The Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships.

30+ days ago

Manager of Regulatory Affairs and Customer Quality Gpac

Watertown, CT

85000–100000
Quick Apply

Trains, coaches and mentors’ personnel to raise level of understanding of concepts related to regulatory compliance, quality, environmental systems, internal auditing, and good practices in documentation and manufacturing. · Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and implement effective corrective actions.

24 days ago

Postdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control Boehringer Ingelheim International GmbH

Ridgefield, CT

Regulatory Expertise: The Fellow will develop basic regulatory expertise/knowledge in one or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a regulatory advocate to achieve common goals for assigned projects. The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs.

30+ days ago

Director, Regulatory Affairs US Product Group - CRM (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$230,400–$345,600 / year

Provides US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g., development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents), with particular emphasis on the US contribution. The Director, US Product Group Regulatory Affairs will proactively participate in US/global cross-functional meetings and discussions, ensuring that US regulatory considerations are incorporated timely and comprehensively at key inflection points and in the decision-making process.

25 days ago

Regulatory Affairs Manager Medtronic

North Haven, Connecticut

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

3 days ago

Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim

Ridgefield, CT

$20–$33 / hour

In the Regulatory Affairs Labeling Ops AI Innovation Co-Op role, your work will help modernize labeling operations through artificial intelligence, automation, and digital solutions—directly impacting how we deliver compliant, patient-centered labeling and regulatory content. This role is focused on utilizing artificial intelligence, automation tools, and digital solutions to modernize labeling operations workflows, drive greater accuracy, seamless system integration, and enhanced operational efficiency.

30+ days ago

Product Safety and Regulatory Affairs Coordinator Global Channel Management

Connecticut

Product Safety and Regulatory Affairs Coordinator duties: Ensure that customers and employees are fully informed about the health and safety characteristics of products and raw materials and that all products marketed by and are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.). Provide timely assessments of developmental materials, including chemical materials and formulations, in order to assure that their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.

30+ days ago

Principal Regulatory Affairs Specialist 5 Star Recruitment

Trumbull, Connecticut

Must-Haves 8+ years working in regulatory affairs in the consumer goods industry, must be within chemical related product lines (laundry detergents, household cleaning products, etc.)• 8+ years experience working with both federal and state regulatory compliance• 5+ years with product labeling experience - need solid knowledge of labeling review and compliance• BS degree in technical field. Partner with key stakeholders, including but not limited to Marketing, Legal and Product Development, and provide regulatory input in support of product development, ensuring regulatory requirements are communicated and elevated, where appropriate.

30+ days ago

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) CEFALY Technology

Darien, CT

Remote

$160,000–$180,000

30+ days ago

Manager of Regulatory Affairs - Southern CT K.A. Recruiting

Norwalk, CT

Quick Apply

Ability to accurately complete and analyze regulatory data, produce accurate and detailed written reports. They lead investigations, complete Cause Analyses/Plans of Correction, and promote a culture of safety and quality care.

26 days ago

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) (Remote) CEFALY Technology

Darien, CT

Remote

30+ days ago

Pesticide Regulatory Affairs Specialist Global Channel Management

Bridgeport, Connecticut

Pesticide Regulatory Affairs Specialist needs 5 years of experience in pesticide product registration; or equivalent combination of education and experience. Pesticide Regulatory Affairs Specialist requires: * Submission of pesticide registration applications, product labels, offers-to-pay, data matrices, etc.

30+ days ago

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Regulatory Affairs Jobs in New Haven, CT

Vice President, Regulatory Affairs The Cooper Companies Inc

Senior Regulatory Affairs Specialist Yale University

Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer Ingelheim

Regulatory Affairs Analyst Yale University

Assistant Director, Regulatory Affairs Yale University

Director Quality Systems & Regulatory Affairs Remote - East Coast Cefaly Technology sprl

Regulatory Affairs Specialist Globalchannelmanagement

Post-Doctoral Regulatory Affairs Fellow - Advertising and Promotion Boehringer Ingelheim International GmbH

Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer Ingelheim

Manager of Regulatory Affairs and Customer Quality Gpac

Postdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control Boehringer Ingelheim International GmbH

Director, Regulatory Affairs US Product Group - CRM (Hybrid) Boehringer Ingelheim International GmbH

Regulatory Affairs Manager Medtronic

Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim

Product Safety and Regulatory Affairs Coordinator Global Channel Management

Principal Regulatory Affairs Specialist 5 Star Recruitment

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) CEFALY Technology

Manager of Regulatory Affairs - Southern CT K.A. Recruiting

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) (Remote) CEFALY Technology

Pesticide Regulatory Affairs Specialist Global Channel Management

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