104 Results for

Director Of Regulatory Affairs Jobs in New York, NY

Jobs

Warren, NJ9 days ago

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.

New!

Bernards, NJ1 day ago

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.

Bernards, NJ12 days ago

Lead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.

Bernards, NJ9 days ago

This role will influence the external policy landscape so the value of Daiichi Sankyo's pipeline, portfolio, and business is protected and enhanced – allowing Daiichi Sankyo to continue bringing innovative medicines to patients who need them. Leverage subject matter expertise to assess potential policy implications to Daiichi Sankyo with internal stakeholders (e.g., Market Access, Regulatory Intelligence, etc.), develop DSI policy strategies and shape policy reform.

New!

Summit, NJToday

$180,000–$205,000

With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Brooklyn, NY8 days ago

PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Located in the heart of Brooklyn, Kings County Hospital accommodates more than 518,076 outpatient visits, more than 141,328 emergency room visits, 627 beds, and more than 25,000 inpatient admissions annually.

New!

Bernards, NJ1 day ago

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.

New!

Bernards, NJ6 days ago

Provide oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers. Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed.

Totowa, NJ11 days ago

$90,000–$100,000 Per Year
Full-time
Employee

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.

New!

Long Island City, NY4 days ago

$48,647–$59,444 Per Year
Full-time
Employee

CREAR (College Readiness, Achievement, and Retention) Futuros—meaning “to create futures”—is a national, Hispanic Federation–powered peer mentorship initiative designed to promote college access, retention, academic success, leadership development, and graduation among Latinx students, while remaining open to all eligible students regardless of background. At LaGuardia Community College, CREAR Futuros is housed within Casa de las Américas, a student-centered cultural and academic hub advancing the educational, professional, and leadership development of Latinx, Latin American, and Caribbean students through high-impact and culturally informed programming.

Warren, NJ30+ days ago

$180,000–$220,000 Per Year
Full-time

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.

New York City, NY30+ days ago

Remote

$160,000–$215,000 Per Year

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.

Warren, NJ30 days ago

$190,000–$220,000 Per Year

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.

Summit, NJ7 days ago

$40–$47 Per Year
Temporary
Contractor
Full-time

Support the shaping and lead the execution of Neutrogena Makeup communication campaigns, partnering with multifunctional teams and leading creative and influencer agencies to deliver campaigns that drive mental availability for the brand and platform. The Brand Manager for Global Makeup is responsible for identifying and executing innovation, claims and communications required to drive global growth on the Makeup platform.

Parsippany, New Jersey30+ days ago

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.

Cranbury, New Jersey30+ days ago

$204,000–$244,000 Per Year

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.

Brooklyn, NY30+ days ago

$100,000–$125,000 Per Year

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.

New!

New York, NY1 day ago

$175,000–$225,000 Per Year

Reporting to the Chief Medical Officer, this leader will elevate Cellectis’ scientific presence, support pipeline advancement, and ensure medical excellence in evidence generation, scientific communications, and external engagement. Cellectis is seeking a highly experienced Senior Director, Medical Affairs to help shape and operationalize the company’s medical affairs strategy across its clinical‑stage portfolio.

New York City, NY30+ days ago

Remote

$79,488–$104,328 Per Year

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.

Madison, NJ30+ days ago

$207,490–$251,433 Per Year

This individual will be involved in integrated strategic planning within Global Medical Affairs under the direction of the US Medical Multiple Myeloma lead and Global Multiple Myeloma disease lead as well as in close partnership with the US Commercialization organization, Clinical Research and Development, HEOR, Market Access, Translational Development, and Regulatory, and will lead the US Medical asset strategy supporting the US and Global Multiple Myeloma Disease Leads. Provide high quality clinical input and review of congress abstracts, posters, presentation slides, manuscripts, educational materials, steering committee and advisory board meeting materials, medical information response documents, scientific educational grant requests, compassionate use requests, and patient advocacy grant requests among others.

New York, NY30 days ago

Remote

$183,549–$275,324 Per Year

The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. As a key cross-functional partner, the Medical Director collaborates closely with Commercial, Clinical Development, Regulatory, and Market Access teams, among others, to shape brand and portfolio strategy, integrating real-world evidence and external expert perspectives.

Florham Park, New Jersey30+ days ago

$280,000–$325,000 Per Year

Overview: The Senior Medical Director, Global Medical Affairs (Virology) provides global medical/scientific leadership for assigned assets, serving as a subject matter expert and strategic partner across cross-functional teams. Responsibilities: Provide end-to-end global scientific leadership and medical strategy for assigned assets, including accountability for asset-level Medical Affairs budgets, tracking, and compliance in alignment with Global Medical strategy.

New!

Paramus, New Jersey6 days ago

Qualifications: Bachelor’s degree required, advanced degree strongly preferred (eg, PharmD, PhD, MD), 10+ years experience in Medical Affairs with Bachelor’s degree; 8+ years of experience with advanced degree; experience in the therapeutic area of Neuroscience/CNS is highly preferred, Prior experience in analytics, business intelligence, or related function within the pharmaceutical or biotech industry is preferred, Prior experience in MSL operations, including analytics of field scientific interactions, is preferred, Experience with visualization tools (e.g., Tableau) and CRM systems (e.g., Veeva). Overview: The Senior Director, Medical Affairs Insights & Field Operations, is responsible for supporting a high-performance Medical Science Liaison (MSL) team through strategic planning, performance analytics, and the development of scientific content related to our product, pipeline, and disease state education.

New York City, NY30+ days ago

$198,720–$260,820 Per Year

You will manage a third-party vendor responsible for building and operating a new national coalition, you will ensure alignment between coalition activity and Oscar's federal and state policy and advocacy objectives, you will translate complex healthcare and technology policy issues into coordinated advocacy and thought-leadership initiatives among a diverse group of external stakeholders. Designs and maintains the strategic framework for Oscar's external coalition; define mission, membership criteria, governance structure, messaging pillars, and policy priorities in alignment with Government Affairs colleagues, communications partners, and key internal business and strategy stakeholders.

Madison, NJ30+ days ago

$229,380–$278,000 Per Year

The MAPs Lead will provide strategic input, oversight, and coordination to ensure a streamlined and efficient approach to managed access and ensure equity, sustainability, scalability, and appropriate data capture across their respective disease areas. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.

White Plains, NY30+ days ago

Whether building technology to make our hospitals more efficient, recruiting and growing incredible VEGgies, or bringing our brand to life through marketing, our VQ (VEG Headquarters) team makes it all possible—ensuring our hospitals and people have everything they need to help pets and their families. Strategic Legal Partnership: Serve as a trusted advisor to VEG's business and clinical teams by delivering proactive, business-minded legal guidance that enables smart, fast decision-making.

Monmouth Junction, New Jersey30+ days ago

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.

Piscataway, NJ30+ days ago

$124,000–$174,000 Per Year

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).

Piscataway, NJ30+ days ago

$124,000–$174,000 Per Year

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).

New!

Newark, NJ3 days ago

$38,100–$57,200 Per Year

If applicable, the successful applicant must prove they are: (1) a citizen or national of the USA; OR (2) a lawful permanent resident of the United States (Non-Conditional Permanent I-551 / Green Card / Permanent Resident Card holder); OR (3) a citizen, national, or permanent resident of a “Generally Authorized” destination on the attached list (https://corporate.pseg.com/-/media/PSEG/Corporate/Careers/Careers Assignments will include working alongside professionals in the following areas: + Sustainability Data Analytics: Gather and analyze enterprise sustainability data, determine qualitative and quantitative insights, conduct industry analysis and present findings to team members as needed to address the company’s strategy on sustainability, affordability and reliability.

New!

Florham Park, New Jersey5 days ago

$120,000–$150,000 Per Year

The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and escalates as needed to support successful regulatory outcomes.

Purchase, NY30+ days ago

$106,400–$178,100 Per Year

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.-

Madison, NJ30+ days ago

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.

New York City, NY30+ days ago

$163,944–$215,176 Per Year

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.

Madison, NJ30+ days ago

$265,460–$321,700 Per Year

The Executive Director, Medical Affairs Strategy and Operations Head is responsible for leading a team of S&O colleagues and project managers who are charged with partnering with colleagues in WW Medical Affairs or in other functions to lead or support the business operations and execution of the oncology portfolio. There is a critical need in this complex ecosystem of therapeutic assets and disease areas to bring rigorous strategy and execution to portfolio optimization, evidence generation across the portfolio and to ensure effective, repeatable launches that will benefit patients.

New!

Parsippany, New Jersey3 days ago

$229,000–$301,000 Per Year

The Executive Director, Head of Biometrics, will serve as the company’s biometrics leader, providing strategic and hands-on leadership across biostatistics and statistical programming to support clinical development and regulatory submissions. This role is accountable for biometrics strategy, high-quality deliverables, and effective vendor oversight, while partnering cross-functionally to ensure data-driven decision-making across the portfolio.

New Brunswick, NJ30+ days ago

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.

Stamford, CT7 days ago

$125,000–$150,000

This is a high-impact opportunity for a government affairs leader who can balance strategic thinking with hands-on execution to influence public policy outcomes and protect long-term business interests. Our client, a global consumer products company, is seeking a Government Affairs Manager to lead the development and execution of a comprehensive government affairs strategy aligned with corporate goals and priorities.

Totowa, NJ30+ days ago

Full-time

Responsibilities: The General Affairs & Operations Specialist - Manager is responsible for providing strategic oversight of the company's operational infrastructure and non-payroll expenditures through a variety of tasks, including:Operational Support & Office ManagementOversee day-to-day office operations, including space planning, office supplies procurement, and mail/logistics management to ensure a seamless work environment. The General Affairs & Operations Specialist - Manager provides strategic operational oversight by managing the company’s non-payroll expenditure, physical infrastructure, and contractual ecosystem.

Manhattan, NY30+ days ago

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.

New York, NY30+ days ago

$76,800–$100,800 Per Year

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, NY30 days ago

Remote

$229,562–$344,342 Per Year

The role oversees a high-impact team and partners cross-functionally and externally to drive an integrated publications and scientific communications strategy, translating complex data into compelling evidence that supports clinical adoption, informs healthcare decision-making, and differentiates the company’s portfolio globally. Agios Pharmaceuticals is searching for a dynamic Senior Director, Global Scientific Communications and Publications expert to join our Global Medical Affairs team and lead a high-functioning communications/publications/congress team.

Parsippany, NJ12 days ago

$185,000–$271,000 Per Year

Demonstrate initiative and analytical insight to ensure that key account market trends, challenges and opportunities, and the Company's response to those trends, challenges and opportunities, are effectively communicated across Commercial Operations Leverage leadership and collaboration skills to manage, develop, and provide guidance to Key Customers, specifically, Key Accounts, and KOLs. The primary responsibility of the Director of Key Account Management is to provide leadership, vision, coaching, support, and mentorship to their KAMs and the entire Uro-Oncology commercial field organization, and to maximize the Uro-Oncology portfolio within East Area.

Florham Park, New Jersey30+ days ago

$250,000–$290,000 Per Year

Represents SI MA scientific communications team to internal/external stakeholders such as the Global Publications team, Commercial teams, global teams, healthcare professionals, key opinion leaders, regulatory agencies, and broader medical community. Demonstrated experience leading publication and data‑release impact assessment, reach, and amplification strategies, including measurement of scientific dissemination across congress, digital, and field medical channels; and demonstrated experience leading omnichannel strategies and online medical digital approaches.

Parsippany, NJ17 days ago

$215,000–$268,000 Per Year

Requirements: Bachelor's degree in engineering (Mechanical, Electrical, Chemical, or related field) required Master’s degree (MS Engineering) preferred 10+ years of engineering and maintenance experience including significant experience in pharmaceuticals manufacturing (GMP) 7+ years of direct people leadership experience, managing managers, engineers, technicians, and cross-functional technical teams At least 5 years of experience supporting complex manufacturing operations Demonstrated experience with cleanroom operations and critical utility systems Experience with CMMS, reliability-centered maintenance, and asset management systems Proven project management and capital execution experience Strategic thinker with strong leadership and decision-making skills Excellent communication and cross-functional collaboration abilities Strong problem-solving and root cause analysis capabilities Physical Requirements: Occasional off-hours and on-call support required for critical manufacturing operations Role will be in Parsippany, NJ. Engineering & Technical Operations Provide engineering oversight for critical utilities and systems, including: HVAC systems (classified cleanroom environments) Water for Injection (WFI), Purified Water (PW), and clean steam systems Compressed air and nitrogen systems Lead root cause investigations for equipment and system failures and implement robust CAPAs.

New York City, NY30+ days ago

Remote

$170,000–$225,000 Per Year

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. This role will collaborate cross functionally with Market Access, Regional Marketing, Patient Marketing, Patient Support Services, Sales, Market Access, Data & Market Analytics, as well as other internal and external partners.

New York City, NY30+ days ago

Remote

$160,000–$200,000 Per Year

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. The Associate Director/Director, Government Pricing will be responsible for ensuring compliance with federal and state price reporting regulations, reviewing pricing strategies, ensuring the accuracy and timeliness of Medicaid rebate payments, and collaborating with internal teams to support business objectives.

Jersey City, NJ28 days ago

The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.

Nutley, NJ30+ days ago

The Associate Director/Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL).

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Director Of Regulatory Affairs Jobs in New York, NY

Jobs

Director, Regulatory Affairs StrategyAquestive Therapeutics

Manager, Medical Affairs Quality, RD PV QADaiichi Sankyo, Inc.

Senior Director, Clinical Safety ScientistDaiichi Sankyo, Inc.

Associate Director, Public PolicyDaiichi Sankyo, Inc.

Associate Director, US Brand MarketingCSL Seqirus

Associate Director, Patient Safety and Risk Management - NYC Health + Hospitals/Kings County - Brooklyn, New YorkPhysician Affiliate Group of New York

Senior Director, Global Clinical LeadDaiichi Sankyo, Inc.

Associate Director, PV Strategic Partner ManagementDaiichi Sankyo, Inc.

Quality Manager, PartnersSOFIE

CREAR Futuros Program Coordinator (Academic Program Coordinator)LaGuardia Community College

Director, Regulatory Affairs StrategyMonosol Rx, LLC

Associate Director/Director, Regulatory AffairsAxsome Therapeutics

Director, Regulatory Affairs StrategyJudge Group

Global Brand ManagerYANTRAN LLC

Senior Director, Regulatory Affairs Advertising, Promotion, & LabelingPacira Pharmaceuticals, Inc.

Director, Regulatory Affairs – CMCRocket Pharmaceuticals

Manager, Policy and Regulatory AffairsEnergyHub

Senior Director, Medical AffairsCellectis

Senior Analyst, Regulatory AffairsOscar Health

Director, US Medical Affairs, Multiple MyelomaBristol Myers Squibb

Medical Director, Global Medical Affairs - RemoteAgios Pharmaceuticals

Senior Medical Director, Global Medical Affairs (Virology)Shionogi Inc.

Senior Director, Medical Affairs Insights & Field OperationsSK Life Science, Inc.

Director, Public AffairsOscar Health

Senior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs)Bristol Myers Squibb

Senior Director, Legal AffairsVeterinary Emergency Group (VEG)

Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)Essenlix

Consumer Affairs Global Systems & Ops ManagerColgate-Palmolive

Consumer Affairs Global Systems & Ops Manager (Piscataway, NJ, US)Colgate-Palmolive Company

Summer 2026 Staff Intern - Corporate Citizenship - Federal Affairs & SustainabilityPSEG

Manager, Regulatory Affairs - GDPShionogi Inc.

Government Affairs Manager (North East)PepsiCo North America Beverages

Regulatory and Medical affairs - Sr. Manager, US MedicalTechDigital Corporation

Director, Corporate and Regulatory ComplianceOscar Health

Executive Director, WW Medical Oncology, Head of Strategy and OperationsBristol Myers Squibb

Executive Director, Head of BiometricsPacira Pharmaceuticals, Inc.

Quality - Regulatory Operations ManagerTechDigital Corporation

Government Affairs ManagerCoastal Wave Recruiting

General Affairs & Operations Specialist - Manager - Cosmetics & SkincareEnglewood Lab, Inc.

Regulatory Guidance ManagerAMERICAN CYBERSYSTEMS INC.

Senior Analyst, RegulatoryOscar

Senior Director, Global Scientific Communications and Publications - RemoteAgios Pharmaceuticals

Director, Key Account Management, Uro-Oncology - WestFerring Pharmaceuticals, Inc.

Director/Senior Director, Scientific CommunicationsShionogi Inc.

Director, Engineering and MaintenanceFerring Pharmaceuticals, Inc.

Associate Director/Director, Long Term Care Marketing (Alzheimer's Disease Agitation)Axsome Therapeutics

Associate Director/Director, Government PricingAxsome Therapeutics

Executive Medical Director, Clinical Development - M.D. (Nephrology)Clinical Dynamix, Inc.

Associate Director/Director, Medical Science Liaison - Oncology, (Central Region)Eisai

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