Entry Level Regulatory Manager Jobs in New York, NY
Aquestive Therapeutics
Warren, NJ
This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
Daiichi Sankyo, Inc.
Bernards, NJ
Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues. Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.
Daiichi Sankyo, Inc.
Bernards, NJ
The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
Daiichi Sankyo, Inc.
Bernards, NJ
CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
SOFIE
$90000 - $100000
Totowa, NJ
The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
Flagstar Bank
$84878 - $112463
Rockville Centre, NY
Reviews various reports including check fraud, significant activity, significant change, large deposit, detailed transaction report and month-end reports; investigate & approve when needed. Develops and expands existing relationships including sales efforts; engages key Product Partners as appropriate in delivering the full breadth of the bank to satisfy clients needs.
ECLARO
$55.74 - $62.43
Parsippany, NJ
Stakeholder Engagement:Identifies and manages key business partner relationships, listens to and understands their needs and expectations, maintains open two-way communication and delivers value to business partner. Building a Business Case:Articulates the presenting business issue impacting own team and helps develop the rationale for addressing it (e.g., impact on customer satisfaction scores or team revenues).
Daiichi Sankyo, Inc.
Bernards, NJ
CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
VNS Health
$85000 - $106300
New York, NY
Minimum two years of clinical assessment, homecare or hospital experience requiredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness requiredDemonstrated successful conflict management skills and negotiation of “win-win” solutions requiredWorking knowledge of Microsoft Excel, Power-Point, and Word requiredKnowledge of Medicaid and/or Medicare regulations requiredWorking Knowledge of UAS-NY preferred . Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond.
VNS Health
$85000 - $106300
New York, NY
Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond. • Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan.
Daiichi Sankyo, Inc.
Bernards, NJ
Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Define the vision and mission of the group; manage statistical programming resources to support project needs; be accountable for the quality of the statistical programming deliverables; be responsible for recruiting, retaining, developing, and managing employees; be responsible for talent development including providing guidance for career growth and providing development opportunities for the direct reports.
SOFIE
Totowa, NJ
Perform the duties associated with manufacturing, compounding, dispensing, and distribution of radiopharmaceuticals, including data entry with Pinestar for end-of-day reports and daily dose management reports. § Ability to effectively present information and respond to questions or complaints from groups of managers, clients, customers, the public required, or regulatory agencies required.
Inizio Engage
Edison, NJ
Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. This highly visible role will lead the execution of aligned marketing tactics across Healthcare Professional (HCP) and Consumer/Patient audiences, spanning personal promotion, non-personal promotion, digital media, communications, public relations, and additional strategic channels.
Daiichi Sankyo, Inc.
Bernards, NJ
Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
EnergyHub
$100000 - $125000
Brooklyn, NY
Prioritize the highest-leverage advocacy opportunities and initiatives related to grid modernization, integrated resource planning, demand-side management, transportation electrification, energy storage, rate cases, state and federal legislation and grant programs, etc. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
Rockefeller University
New York, New York
Overview: Reporting to the Director of Operations, the Regulatory Affairs Manager has a strong operational focus, ensures compliance with New York State laws and regulations, and leads regulatory processes for the Diagnostic and Treatment Center's (D&TC) clinical operations. The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training.
Essenlix
Monmouth Junction, New Jersey
Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.
Lupin Pharmaceuticals Inc.
Somerset, NJ
The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.
Monosol Rx, LLC
Warren, NJ
Strong knowledge of current US and global regulations/gui Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team Proven ability to communicate with executive management and external thought leaders. This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones.
CEDENT
Hackensack, NJ
The client is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day to day Quality and Regulatory systems. KEY RESPONSIBILITIES:Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management.
TechDigital Corporation
New Brunswick, NJ
The External Manufacturing Quality Organization is seeking to recruit a Manager, Regulatory Affairs who will report directly to the Associate Director, Regulatory Affairs and will be responsible for all regulatory support activities within External Manufacturing. Reports, CoA's, Analytical raw data) to support regulatory requests for post approval variations, renewals, and.
AMERICAN CYBERSYSTEMS INC.
Manhattan, NY
An Innova Solutions Client is immediately hiring for a Regulatory Guidance Manager - Government Programs Position type: Full-time/Direct Hire Location: New York, NY (REMOTE, must be within commuting distance to NYC) Regulatory Guidance Manager - Government Programs The Regulatory Guidance Manager is responsible for ensuring regulatory compliance by disseminating guidance to affected business units. Benefits provided by client as this is a Direct Hire position ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion.
TechDigital Corporation
Madison, NJ
In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Judge Group
$180000 - $210000
Warren, NJ
This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.
Axsome Therapeutics
$160000 - $215000
New York City, NY
Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.
WD-40 COMPANY
Pine Brook, New Jersey
In this pivotal role, you’ll drive our global regulatory strategies, coordinate cross-functional councils, integrate cutting-edge technologies like AI, manage regulatory budgets and resources, develop training programs, and ensure compliance for our products and laboratory operations. Interpret complex, multi-regional and ambiguous regulatory requirements, developing organizational positions in areas of uncertainty, and influencing commercial decision-making to reduce regulatory risk while enabling business growth.
TechDigital Corporation
Summit, NJ
2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
Tris Pharma, Inc
$200000 - $245000
Monmouth Junction, NJ
DescriptionTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. This role is well-suited for a regulatory professional who thrives in lean biotech environments, is comfortable working with ambiguity and can seamlessly shift between strategy input and tactical execution.
Oscar Health
$79488 - $104328
New York City, NY
Manage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Pacira Pharmaceuticals, Inc.
Parsippany, New Jersey
Establish and oversee formal processes to provide regulatory support in the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as the internal Company Core Data Sheet). The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
Kleinfelder Inc
$68000 - $86000
Linden, New Jersey
Our collaborative, multidisciplinary group spanning architectural, structural, civil, electrical, mechanical, process engineering, pipeline design, and integrity management works together to deliver integrated, high‑impact solutions. 1-4 years of relative experience or willingness to learn site/civil design including site grading, stormwater analysis, erosion/sediment control measures and earthworks estimation.
Rocket Pharmaceuticals
$204000 - $244000
Cranbury, New Jersey
Position Summary: Rocket Pharma is seeking a Director, Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy. They will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.
Bank of China Limited, New York Branch
$110000 - $230000
New York, New York
Oversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
Axelon Services Corporation
Valhalla, NY
The primary focus of this position is to support graphic refreshes of the Beverages portfolio which includes the development of the nutrition and ingredient label declarations that are compliant with US FDA regulations, as well as support updates to legacy label information documentation. The position will require a basic understanding and application of US Food and Drug Administration labeling regulations to ensure the accuracy and regulatory compliance of ingredient statements, nutrition facts, allergen declarations, and claims.
IntelliPro Group Inc.
Clark, NJ
This role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Rocket Pharmaceuticals
$360000 - $400000
Cranbury, New Jersey
Advises leadership team and Board on regulatory strategy and execution for early and late-stage programs, CMC, nonclinical and commercial activities, as well as advice on areas of regulatory risk, and updates on new governmental/regulatory developments. As the company continues to scale, the incumbent will have the ability to contribute to the organizational build and directly impact patients’ lives by gaining approval for, and delivering on, critical gene therapy products for rare and undertreated diseases.
Bank of China
$110000 - $230000
New York, New York
Oversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. Overview: Regulatory Affairs Office (“RAO”) serves as the liaison between the Bank and regulatory agencies to manage compliance-related regulatory matters, coordinate regulatory examinations and ad hoc inquiries, organize regulatory information, and provide periodic updates.
Bank of China Limited, New York Branch
$110000 - $230000
New York, New York
Oversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. Overview: Regulatory Affairs Office (“RAO”) serves as the liaison between the Bank and regulatory agencies to manage compliance-related regulatory matters, coordinate regulatory examinations and ad hoc inquiries, organize regulatory information, and provide periodic updates.
Noven Pharmaceuticals
Jersey City, New Jersey
Additionally, the intern will have an opportunity to learn from and work with other functions within Product Development, such as Pharmacovigilance, Clinical Development and Medical Affairs to work on ad hoc projects and understand the roles of these functions within pharmaceutical industry. Effective written and oral communication skills are important, along with the ability to interact successfully with your supervisor and associates in varied areas of expertise.
Amneal Pharmaceuticals
Piscataway, NJ
Assists in organizing meetings with FDA or other Health Authorities, including submitting the meeting requests, setting up internal preparation meetings, assist meeting leads in preparing presentations and talking points, and type-up meeting minutes. Description: The Regulatory Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.
Oscar
$76800 - $100800
New York, NY
In assigned jurisdictions, the Senior Analyst, Regulatory Affairs will intake disputes from providers, participate in negotiation with team support, and prepare arbitration briefing where needed, all while maintaining detailed documentation for tracking purposes. Support the wider team and Regulatory Affairs Counsel with preparing concise, user-friendly briefing summaries and analyses based on case needs.
New York Blood Center Inc
Rye, NY
NYBCe operates Blood Bank of Delmarva, Community Blood Center of Kansas City, Connecticut Blood Center, Memorial Blood Centers, Nebraska Community Blood Bank, New Jersey Blood Services, New York Blood Center, and Rhode Island Blood Center, delivering one million blood products to 400+ U.S. hospitals annually. The Director, Quality and Regulatory Compliance (CCS) leads quality, compliance, and regulatory initiatives in support of NYBCe’s Comprehensive Cell Solutions (CCS) business unit across all geographic regions, including cell therapy collections, product development, clinical trials, and contract manufacturing of cellular therapies.
Benjamin Moore & Co
$75000 - $96000
Montvale, New Jersey
This role is responsible for preparing and reviewing regulatory documents (Safety Data Sheets and Product Labels) and ensuring product safety and regulatory compliance for paints and coatings in North America. The candidate will collaborate with cross-functional teams to provide a regulatory perspective for ongoing and upcoming initiatives within the organization and represent Benjamin Moore in industry groups (ACA).
Shionogi Inc.
$90000 - $120000
Florham Park, New Jersey
The scope of this role includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvements. Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive).
PepsiCo North America Beverages
$106400 - $178100
Purchase, NY
Qualifications- Bachelor's degree in Political Science, public policy, Legal, Economics or related field required- 5+ years of relevant experience in legislative affairs or government affairs with state and local focus - Industry exposure to fast moving consumer goods would be highly advantageous- Proven track record in senior stakeholder management and advising the board and leadership on the most effective corporate affairs strategies- Strategic thinking to set direction and shape future environment as well as executional excellence- Strong communication skills; must also be able to effectively communicate with executives, government and general audiences. WORK WITH AND SHAPE INDUSTRY BODIES, TRADE ASSOCIATIONS AND GOVERNMENT AFFAIRS- Establish and manage relationships with relevant industry associations and ensure PepsiCo is part of the larger government-private sector consultative process.- Represent the Company on key government and industry representative bodies, governance structures and in external meetings with third parties and various industry/trade associations, etc.- Ensure PepsiCo’s position is understood and shape/impact industry-positioning to align with PepsiCo key materiality frameworks and facts.-
Colgate-Palmolive
$124000 - $174000
Piscataway, NJ
This high-impact role, sitting within the Global Consumer Affairs Team, reporting to the Senior Director of Global Consumer Affairs, is critical to the functional transformation of our worldwide Consumer Affairs organization, ensuring our technology strategy is flawlessly aligned and executed to provide a compliant, efficient, and best-in-class consumer experience across all divisions. + Technical competency: Ability to translate business needs into technical requirements, manage SaaS vendors and IT partners, understand APIs/integrations at a working level and govern change processes (SLAs, root cause, CAPA, validation readiness).
Colgate-Palmolive Company
$124000 - $174000
Piscataway, NJ
This high-impact role, sitting within the Global Consumer Affairs Team, reporting to the Senior Director of Global Consumer Affairs, is critical to the functional transformation of our worldwide Consumer Affairs organization, ensuring our technology strategy is flawlessly aligned and executed to provide a compliant, efficient, and best-in-class consumer experience across all divisions. Technical competency: Ability to translate business needs into technical requirements, manage SaaS vendors and IT partners, understand APIs/integrations at a working level and govern change processes (SLAs, root cause, CAPA, validation readiness).
TechDigital Corporation
Madison, NJ
Critically review and provide solutions to complex promotional strategies and tactics to ensure balance of the messages, medical accuracy and appropriateness of the content of the materials/activities in accordance with relevant guidance. Contributes strong medical advice for interdisciplinary meetings and related initiatives including promotional review, disease/brand and launch planning, labeling changes, business reviews, etc.
Genadyne Biotechnologies
Hicksville, NY
Seeking a motivated, intelligent and hard-working individual to Develop and maintain quality and regulatory compliance in Genadynes' processes. Maintaining the effectiveness of quality control system and non-conforming materials control system.
Oscar Health
$163944 - $215176
New York City, NY
The Director, Corporate and Regulatory Compliance is responsible for designing, implementing, training, investigating, monitoring, and enforcing, when necessary, programs, policies, and practices to ensure all applicable operational functions are in compliance with and maintains compliance with federal, state and local regulatory requirements. In collaboration with the Legal and Government Affairs functions, manage Oscar's relationship with various regulatory entities in order to facilitate tech-driven innovation, remediate identified noncompliance, and meet or exceed Compliance Program Effectiveness requirements.