NewRecords & Information Specialist ECLARORecords & Information SpecialistWhite Plains, NYPosition Overview: The Records & Information Specialist role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Familiarity working with a Records Retention Schedule by associating documents with their Record Series Titles, retention periods, regulations, and RM File Numbers.
Regulatory Affairs Specialist Regulatory Affairs Specialist LancesoftRegulatory Affairs Specialist Regulatory Affairs SpecialistTrumbull, CT$30Skills —strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Manage workload, priority and performance of regulatory staff, in addition to providing development opportunities to build capability.
Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer IngelheimSenior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBERidgefield, CT$170,000–$269,000 / yearIf 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.
Senior Regulatory Affairs Specialist Yale UniversitySenior Regulatory Affairs SpecialistNew Haven, CT$82,000–$131,500 / yearReporting 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.
Director/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid) Boehringer Ingelheim International GmbHDirector/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid)Ridgefield, CT$170,000–$269,000 / yearProvides 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 or Senior Associate 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.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsManager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$128,600–$210,000 / yearHelp 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.
Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$150,500–$245,500 / yearHelp 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 minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Regulatory Affairs Admin Asst Life's WORCRegulatory Affairs Admin AsstGarden City, New YorkExcellent verbal & written communication skills, excellent organizational & time management skills, as well as excellent customer service skills. Assist with follow up on incident items needed from various departments to ensure incidents are completed/closed within the regulatory timeframe.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncAssociate Manager, Regulatory Affairs Strategy - OncologyTarrytown, NY$109,900–$179,300 / yearDiscover 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.
Assistant Director, Regulatory Affairs Yale UniversityAssistant Director, Regulatory AffairsNew Haven, CT$105,000–$174,000 / yearReporting 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.
Director Quality Systems & Regulatory Affairs Remote - East Coast Cefaly Technology sprlDirector Quality Systems & Regulatory Affairs Remote - East CoastDarien, CTRemote$160,000–$180,000 / yearA 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.
Manager, Regulatory Affairs Strategy - Oncology Regeneron PharmaceuticalsManager, Regulatory Affairs Strategy - OncologyTarrytown, NY$128,600–$210,000 / yearDiscover 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.
Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - Immunology & InflammationTARRYTOWN, NY$128,600–$210,000 / yearA typical day might include the following: 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.
Regulatory Affairs Specialist GlobalchannelmanagementRegulatory Affairs SpecialistTrumbull, CTStrong 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.
Regulatory Affairs Analyst Adults and Children with Learning and Disabilities IncRegulatory Affairs AnalystBethpage, NYProvide 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.
Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer IngelheimExecutive Director, Regulatory Affairs, Advertising and PromotionRidgefield, CT$250,000–$394,000 / yearThe 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.
NewPost-Doctoral Regulatory Affairs Fellow - Advertising and Promotion Boehringer Ingelheim International GmbHPost-Doctoral Regulatory Affairs Fellow - Advertising and PromotionRidgefield, CTThe 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.
Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer IngelheimRegulatory Affairs Labeling Operations AI Innovation Co-opRidgefield, CT$20–$33 / hourIn 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.
NewPostdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control Boehringer Ingelheim International GmbHPostdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & ControlRidgefield, CTRegulatory 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.
Principal Regulatory Affairs Specialist 5 Star RecruitmentPrincipal Regulatory Affairs SpecialistTrumbull, ConnecticutPartner 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. 8+ years working in regulatory affairs in the consumer goods industry, must be within chemical related product lines (laundry detergents, household cleaning products, etc.).