48 Results for

Regulatory Affairs Jobs in New Haven, CT

Jobs

Ridgefield, CT30+ days ago

$170,000–$269,000 Per 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.

Rocky Hill, CT27 days ago

Full-time

on W2 (Without benefits) Job Description Responsibilities: Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by Henkel Corporation 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.

Guilford, CT30+ days ago

$130,000–$150,000 Per Year

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop®system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations:Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

Ridgefield, CT30+ days ago

$250,000–$394,000 Per 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.

Ridgefield, CT30+ days ago

$20–$33 Per 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.

Danbury, CT8 days ago

Full-time
Employee

Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure.

New!

New Haven, CTToday

Qualifications MD, PharmD, RN, MPH, or similar graduate degree required 10+ years' experience in healthcare or pharmaceutical industry preferred Minimum 1-3 years in a director-level or senior management role within Medical Affairs, MSL leadership, or medical strategy Deep scientific/clinical expertise in at least one major therapeutic area (e.g., Oncology, Immunology, Neuroscience, Cardiovascular, Rare Disease) Proven ability to develop and execute medical strategies in a cross-functional, matrixed organization Entrepreneurial mindset & comfortable with ambiguity required Excellent communication skills – ability to translate complex scientific data for diverse audiences required Proposal writing and negotiation experience Clinical practice or research experience Experience supporting product launchesWork Environment: This position is full-time on-site in New Haven, CT with 30-50% travel. Oversee MSL field activities including medical education, developing and sharing keymessages, sharing process with health system partners· Develop and implement MSL training curricula covering disease area, product, and scientific communication competencies.·

Ridgefield, CT30+ days ago

$20–$33 Per Hour

This includes evaluating data/databases managed by the Regulatory Affairs team, identifying solutions to simplify and automate data management, and building platforms for data management in alignment with Boehringer Ingelheim’s digitial innovation initiative. Boehringer Ingelheim is currently seeking a talented and innovative Data Science co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility.

Berlin, CT30+ days ago

$155,700–$173,000 Per Year

The successful candidate will provide leadership in developing and evaluating asset health, risk and prioritization planning and modeling, overseeing asset management regulatory obligations, driving lifecycle investment strategies, developing compliance driven transmission line and transmission substation programs, overseeing compliance responsibilities for thermal ratings and CIP toward minimizing reliability risk and maximizing system performance. Asset Strategy Development:Lead the development and implementation of comprehensive asset management plans for electrical infrastructure including substations, transformers, circuit breakers, protection systems, overhead and underground transmission lines.

New Britain, CT11 days ago

Full-time

The Associate Vice President of Advising and Transfer Enrollment Operations plays a critical role in collaborating with CT State leadership across all locations and offices—including advising, enrollment management, academic and student affairs, marketing, and institutional research—to ensure the delivery of high-quality, integrated programs and services that meet the diverse needs of all students. Data & ReportingCollects, evaluates, and analyzes qualitative and quantitative data to develop statewide benchmarks, performance measures, and assessment metrics related to advising, retention, and transfer; produces reports and NECHE documentation for campus stakeholders, senior leadership, and Institutional Research to support data-driven decision-making and strategic planning.

New Britain, CT30+ days ago

Full-time

Connecticut State Community College commits to bold and disruptive change by actively identifying, naming, and dismantling structural racism, systemic poverty, and other barriers; establishing equitable and anti-racist policies and practices; and empowering students, faculty, staff, and administrators to advance racial, social, and economic justice. Master’s degree in accounting, business, student affairs, public administration, or related field together with four (4) or more years of experience in financial aid in a higher education setting, with at least two (2) years of supervisory experience; or a combination of education, training and experience which would lead to the competencies required for successful performance of the position’s essential duties.

Ridgefield, CT30+ days ago

Remote

$170,000–$269,000 Per Year

It works in close collaboration with Clinical Operations, Statistics, Regulatory Affairs, Drug Safety, and other key functions to design robust operational strategies, establish data-driven timelines, and ensure high-quality trial execution across programs. The Clinical Development & Operations Lead (CDOL) is member of Clinical Development Organization responsible for defining and delivering operational strategy for late-phase clinical programs within assigned indications or assets, with a strong focus on speed, quality, and value.

Middlefield, CT30+ days ago

Full-time

For over 50 years, Zygo Corporation in Middlefield, CT, has been a global leader in designing and manufacturing advanced optical metrology systems, ultra-precise optical components, and complex electro-optical systems and assemblies. Due to the nature of Zygo's programs and products, applicants must have the legal right to work in the US and additionally must be legally authorized to access export-controlled information and source code.

Ridgefield, CT30+ days ago

$280,000–$441,000 Per Year

The group lead works closely with critical teams (medical excellence, Go-To-Market (GTM), Analytics & Insights (A&I), Corporate teams, Asset Teams, Real World Evidence (RWE), Marketing/market access, Clinical Development & Operations (CD&O), and others) to align and pull through the US medical strategy and execution. + Ensures that the team is a responsive and trusted source of current medical practice, scientific expertise, and business acumen (e.g., disease states, product label, clinical trial interpretation, competitive landscape, barriers to implementation of guidelines into routine practice, etc.) for internal and external stakeholders.

Ridgefield, CT30+ days ago

$220,000–$350,000 Per Year

definition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development. • Serves as Innovation Team Lead of the cross-functional Innovation Team dependent on project stage and proposes members in collaboration which represents the Innovation Team at the Innovation Unit Portfolio Committee (IUPC), IU Executive Committee (IUEC), and the One Human Pharma Committee (OneHP).

Ridgefield, CT30+ days ago

$280,000–$441,000 Per Year

Depending on the status of development of the compound, may be required to lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound or product including project-specific training and coaching of team members, review of team output. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or support the BI-internal Asset Benefit Risk Team, consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate.

Ridgefield, CT30+ days ago

$280,000–$441,000 Per Year

New Haven, CT15 days ago

Contractor

Collaborate, negotiate, influence and lead in a matrix organization Excellent communication and interpersonal skills Proven record in demonstrating agility We would prefer for you to have: Experience in successful development, filing and Producting approval for global regulatory submissions Experience in development of AI DHT / AI SaMD and regulatory approval 510(K), De Novo or PMA. Job title: Design Quality Lead DHT (Digital Health Technology) Location: New Haven, CT, Hybrid (3 days onsite / 2 days remote) Contract duration: 12 months Interview - 2-round virtual interview This is what you will do: The primary purpose of this position is to build internal QMS oversight for AI DHT or AI SaMD development with business partnering AI DHT / AI SaMD companies.

Ridgefield, CT30+ days ago

$140,000–$222,000 Per Year

Delivering results: + Under the supervision of senior clinical pharmacologist in the group, ensures timely delivery of state-of-the-art CP scientific concepts for decision making throughout clinical drug development and registration including all necessary processes and documentation. Clinical Pharmacology development strategies could include assessment of pharmacokinetic/pharmacodynamic (PK/PD), drug interaction, formulation development, dose selection decision, impact of renal/hepatic impairment, food effect on PK, QT prolongation and pediatric drug development.

West Haven, CT30+ days ago

Maintains OSHA, DEEP, EPA, NFPA and all other Preventative Maintenance programs by carefully managing system access, levels of security, Management of Change and other programs relating to equipment maintenance and history. Work/Life Benefits: Generous paid time off programs; progressive paid holiday schedule (including holiday break between Christmas and New Year’s); 4 weeks of parental paid leave; flexible work schedules including summer hours where applicable.

East Hampton, CT30+ days ago

$97,990–$108,880 Per Year

Supports various internal partners by sharing municipal and community knowledge to move projects towards successful outcomes while balancing company and community needs during small-scale project meetings, municipal project briefings, and town/city council, board, commission, committee and other municipal organization meetings. Works with the Community Relations Team to implement strategies for community and municipal outreach and relationship development; emergency preparedness and response; local and regional economic development; strategic corporate giving; and employee engagement, volunteerism, and business membership activities.

west haven, CT30+ days ago

$80,000–$110,000 Per Year

SIRIS, LLC is a CVE-verified, Service-Disabled Veteran-Owned Small Business (SDVOSB) specializing in construction management, project management, and commissioning services for federal, healthcare, and institutional clients nationwide. You will report to a Program Manager and work closely with VA client representatives, contractors, designers, and internal stakeholders to support informed decision-making, regulatory compliance, and successful project delivery.

Ridgefield, CT30+ days ago

Remote

The fellow will drive innovation in digital endpoints, remote monitoring technologies, and multimodal data analytics to enhance multiple facets of clinical trials—from identifying and recruiting suitable patients to capturing meaningful real-world outcomes such as quality of life, functional capacity, and disease progression. + Conduct statistical analysis of multimodal real-world behavioral data to assess associations with key clinical outcomes of interest (e.g., treatment response, disease progression, adherence, data quality, patient phenotypes/stratification, digital endpoint validation, quality of life).

New Canaan, CT30 days ago

5+ years of progressive accounting experience, including Controller or equivalent leadership experience; nonprofit or independent school experience strongly preferred. The Controller ensures accurate and timely financial information to support strategic decision-making and partners with school leadership to advance the School’s mission across academics, arts, and athletics.

Hamden, Connecticut30+ days ago

Provide excellent customer service to patients and other healthcare team members, with attention to the needs of all staff, with positive feedback from staff and co-workers 1.3. As members of a High Reliability Organization (HRO), every employee should practice CHAMP behavior and strive to make patient safety a top priority.

Hamden, Connecticut30+ days ago

Ridgefield, CT30+ days ago

$220,000–$350,000 Per Year

Responsibilities include but are not limited to strategically leading and providing operational oversight of clinical trial delivery including the planning, conduct, management, and reporting of early phase clinical trials; execution in full compliance with all regulatory (GCP -ICH) and legal requirements; strategic resourcing; ensuring oversight of clinical trial delivery and serving as the point-of-contact for an assigned region outside the U.S. supporting patient and site engagement activities; and leading or participating in strategic initiatives. + Serves as the U.S. Regional Liaison, partnering with internal stakeholders across the U.S. and assigned regions—including Clinical Development Operations, Medical Affairs, and Quality Medicine—to align resourcing and drive effective, coordinated trial delivery through purposeful and consistent communication.

NEW HAVEN, Connecticut30+ days ago

Demonstrates proficiency in prescription processing and preparation by performing the necessary activities which include, but are not limited to: locating and entering patient demographic information into pharmacy computer systems, transcribing new medication orders and processing refill requests, performing necessary mathematical calculations to ensure proper dosage, directions, and quantity entered and selected, assisting in third part prescription adjudication and prescription cost management. Proficiency in mathematical calculations; accuracy; problem solving; attention to detail; knowledge of computer applications including word processing and spreadsheets; ability to learn quickly in a fast-paced environment; ability to learn or perform pharmaceutical compounding, repackaging and labeling including manipulation of raw drug products using appropriate technique: ability to work with computer and technology equipment including the ability to perform basic troubleshooting functions.

NEW HAVEN, Connecticut30+ days ago

5.1 Provide education and training to other pharmacy staff members, pharmacy students and residents, and health care team members, via educational inservice or as a preceptor. Responsibilities: Responsibilities include, but are not limited to: Under collaborative practice: Perform comprehensive medication management by initiating, adjusting and discontinuing medications (ex.

NEW HAVEN, Connecticut27 days ago

The clinical pharmacist supports the vision, mission, and goals of YNHHS and the Department of Pharmacy and demonstrates competency in all basic clinical pharmacist skills. As members of a High Reliability Organization (HRO), every employee should practice CHAMP behavior and strive to make patient safety a top priority.

NEW HAVEN, Connecticut27 days ago

5.1 Provide education and training to other pharmacy staff members, pharmacy students and residents, and health care team members, via educational inservice or as a preceptor. The clinical pharmacist II supports the vision, mission, and goals of YNHHS and the Department of Pharmacy and demonstrates proficiency in all basic clinical pharmacist skills.

NEW HAVEN, Connecticut30+ days ago

New Haven, Connecticut21 days ago

NEW HAVEN, Connecticut19 days ago

NEW HAVEN, Connecticut30+ days ago

5.1 Provide education and training to other pharmacy staff members, pharmacy students and residents, and health care team members, via educational inservice or as a preceptor. The clinical pharmacist II supports the vision, mission, and goals of YNHHS and the Department of Pharmacy and demonstrates proficiency in all basic clinical pharmacist skills.

North Haven, Connecticut30+ days ago

NEW HAVEN, Connecticut21 days ago

Bridgeport, Connecticut30+ days ago

New Haven, Connecticut30+ days ago

Ridgefield, CT30+ days ago

$220,000–$350,000 Per Year

The Go‑to‑Market Strategy Lead for the Consumer Health Hub is responsible for shaping and executing comprehensive strategies that accelerate the growth of Boehringer’s direct‑to‑consumer platform and emerging consumer‑focused business models. + Collaborates with therapeutic area franchises, Value & Access, Human Pharma Operations, IT, Data Privacy, Legal, Compliance, Corporate Affairs, and other cross‑functional partners to ensure alignment across initiatives.

Ridgefield, CT30+ days ago

$170,000–$269,000 Per Year

Supports the U.S. Medical Affairs by shaping evidence strategies that drive successful product launch and clinical adoption by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. + Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting complex phase I-IV clinical trials that represent new challenges and for which project and therapeutic knowledge is not given, such as mega trials or new indications and for complex international R&D projects.

Ridgefield, CT30+ days ago

$170,000–$269,000 Per Year

Advances patient health by developing and implementing internal and external communications programs, including public relations and internal/employee communications, that support the short- and long-term business objectives of BIPI/BIUSA associated with prescription medicines across the entire product life-cycle, including traditional and digital PR and social media activities, and employee communications. + Builds open and collaborative relationships with global PR colleagues in Ingelheim,as well as strong relationships with colleagues in marketing, medical, legal, regulatory departments, corporate communications, patient advocacy, stakeholder relations, government affairs and others based on the specific business need(s) of the assigned therapeutic area(s).

New!

Middletown, CT1 day ago

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Regulatory Affairs Jobs in New Haven, CT

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

Regulatory Affairs Specialist Regulatory Affairs Specialist LanceSoft Inc

Senior Regulatory Affairs Specialist Hyperfine

Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer Ingelheim

Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim

Front Desk Specialist Company Confidential

VP, Medical Affairs & Strategic Engagement Valisure

CMC Regulatory Data Science Co-Op (Hybrid) Boehringer Ingelheim

Manager, Asset Strategy and Regulatory Compliance (Hybrid) Eversource

Associate Vice President of Advising and Transfer Enrollment Operations Connecticut State Community College

Director of Financial Aid, Operations and Outreach Connecticut State Community College

SR AD / Director, Clinical Development Operations Lead (CDOL/SR CDOL), Obesity/MASH - Remote Boehringer Ingelheim

U.S. Trade Compliance Specialist AMETEK, Inc

VP, CDMA TA Group Lead - Oncology Boehringer Ingelheim

Senior Clinical Program Leader/ Clinical Program Leader- Cardio Renal Metabolic Boehringer Ingelheim

Patient Safety Physician, Medical Safety Physician - CRM Boehringer Ingelheim

(Senior) Patient Safety Physician, Medical Safety Physician - Inflammation Boehringer Ingelheim

Design Quality Lead DHT (Digital Health Technology) Integrated Resources, Inc

AD / Senior AD, Clinical Pharmacology Lead Boehringer Ingelheim

Facilities Planning Manager University of New Haven

Community Relations Specialist Eversource

Construction Managers Multiple Engineering Disciplines SIRIS

Post Doctoral Medical Fellow - Digital Health, Clinical Development Boehringer Ingelheim

Controller St. Luke's School

Specialty Clinical Pharmacist Yale New Haven Health

Outpatient Clinical Pharmacist Yale New Haven Health

Country Trial Management Country Lead - United States Boehringer Ingelheim

Pharmacy Intern Central Operations Yale New Haven Health

Transplant and Cellular Therapy Clinical Pharmacist Yale New Haven Health

Ambulatory Clinical Pharmacist I - Multiple Specialties Yale New Haven Health

Clinical Pharmacist - Multispecialty Operations Yale New Haven Health

Clinical Pharmacist -- Emergency Medicine Yale New Haven Health

Clinical Pharmacist - Multi-Specialty Critical Care Yale New Haven Health

Clinical Pharmacist - Internal Medicine Yale New Haven Health

Ambulatory Care Pharmacist - Multispecialty Yale New Haven Health

Clinical Pharmacist, Pediatrics Yale New Haven Health

Multispecialty Pharmacist Yale New Haven Health

Clinical Pharmacist Retail Yale New Haven Health

Clinical Pharmacist, Acute Care and Operations (Night Shift) Yale New Haven Health

Per Diem Pharmacist Yale New Haven Health

Clinical Pharmacist - Multi-Specialty Medicine/Surgical/Operations Yale New Haven Health

ED, Consumer Health Hub GTM Strategy Lead Boehringer Ingelheim

Sr. AD, Senior Principal Clinical Data Science Boehringer Ingelheim

SR AD, Public Relations and Communications Boehringer Ingelheim

Receptionist Trusted Medical PLLC

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