Regulatory Affairs Analyst Jobs in New York
Regulatory affairs analyst jobs in New York are concentrated in New York City, the Hudson Valley biotech corridor, and Long Island's pharmaceutical and medical device clusters, with demand running from entry-level associates through senior regulatory strategists. Major employers with deep, lasting roots in the New York market include Pfizer, Johnson & Johnson, and Regeneron, each maintaining large regulatory teams across product development and submissions. The most sought-after specialties are FDA submissions and compliance, pharmaceutical regulatory strategy, and medical device quality systems. Scan the live roles below and apply to whichever ones fit.
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AVP for Behavioral Health Quality and Regulatory Affairs
Position Summary: The Assistant Vice President (AVP) of Behavioral Health Quality and Regulatory Affairs is a leadership role responsible for overseeing the quality, compliance, and performance improvement efforts across all Behavioral Health services. This position plays a critical role in ensuring the organization meets or exceeds regulatory standards set by the Office of Mental Health (OMH), the Office of Addiction Services and Supports (OASAS), the New York State Justice Center for the Protection of People with Special Needs (NYSJC), and the New Yok State Department of Health (DOH). The AVP serves as a key advisor and subject matter expert in advancing behavioral health care quality, clinical effectiveness, and regulatory compliance. The AVP for Behavioral Health will be responsible for conducting Failure Mode Effects Analysis (FMEA’s) and Root Cause Analyses (RCA’s) including case reviews, deep dives and corrective action plans for all Behavioral Health Services. The AVP has responsibility for Behavioral Health quality improvement and risk reduction strategies.
Job Duties & Essential Functions:
- Support the VP in managing daily operations of the Quality and Regulatory Affairs department to maintain compliance with The Joint Commission, CMS, NYS DOH, OMH, OASAS, NYSJC and other accrediting bodies.
- Coordinate Behavioral Health accreditation readiness activities, regulatory surveys, follow-up corrective actions, and continuous survey preparedness efforts.
- Provide oversight of all Behavioral Health regulatory compliance, ensuring alignment with OMH, OASAS, NYSJC, NIMRS, WISR NYS Web Submission of Investigation Report, AARM NYS Administrative Action Reporting Mechanism and DOH reporting requirements.
- Submit, complete and monitor reporting into the NYSJC, NIMRS, and WISR as required.
- Respond to and manage timely submission of Behavioral Health incidents and sentinel events to required regulatory agencies.
- Provide supporting documentation including investigation reports, case reviews, and timelines to appropriate regulatory agencies in accordance with state and federal regulations.
- Track, trend, and implement policy and process changes in response to Behavioral Health regulatory updates, policy revisions, and documentation standards.
- Lead the development and implementation of Behavioral Health quality improvement initiatives and data-driven performance improvement plans.
- Participate in the investigation and analysis of Behavioral Health safety events, including Root Cause Analyses (RCAs), Failure Mode and Effects Analyses (FMEAs), and near misses.
- Identify and assess Behavioral Health risks related to patient safety, operations, legal liability, and compliance. Track, analyze, and report on risk trends and mitigation strategies.
- Lead Behavioral Health clinical case reviews to evaluate care delivery, identify risks, and recommend improvements.
- Analyze and report Behavioral Health quality metrics and CMS core measures (e.g., eCQMs, Core Measures) to inform program enhancements and risk mitigation strategies.
- Coordinate with leadership on Behavioral Health risk exposure, claim management, and safety event documentation.
- Analyze data from SB Safe and other Behavioral Health quality sources to identify trends and opportunities.
- Monitor SB Safe incidents to ensure timely and accurate follow-up completion as per policy.
- Present SB Safe data to the Incident Review Committee (IRC), identifying trends and opportunities for safety enhancement.
- Manage and oversee the investigation, tracking, and resolution of patient and family complaints and grievances related to Behavioral Health services.
- Ensure grievance responses comply with regulatory requirements, including timeframes and documentation standards.
- Identify trends from Behavioral Health grievance data to inform performance improvement initiatives and report findings to the IRC.
- Provide support to Behavioral Health clinical teams in delivering care that meets standards for safety, quality, and evidence-based practices.
- Serve as a strategic partner to Behavioral Health leadership, Risk Management, Compliance, and other departments to foster a culture of safety, accountability, and excellence.
- Act as a key member of the Behavioral Health Leadership Committee.
- Represent Behavioral Health Quality in meetings, hospital and system committees, workgroups, and during regulatory or accreditation surveys and audits.
- Promote a culture of transparency, accountability, and continuous improvement aligned with SBELIH’s I.C.A.R.E. values.
- Participate in policy review committees and contribute to internal Behavioral Health training efforts, including in-service programs and annual recertification.
- Maintain current knowledge of applicable healthcare laws, regulations, and best practices in Behavioral Health quality, risk, and compliance.
- Perform other related duties as assigned by the Vice President.
Required Experience & Qualifications:
- Bachelor’s degree in nursing or social work required; with Master’s degree within five (5) years from an accredited college or university in Business/Healthcare Administration, Social Work, Nursing Leadership and Administration, Behavioral Health discipline or approved related program.
- Minimum of ten (10) years of combined clinical and administrative experience in a Behavioral Health setting.
- Knowledge of clinical documentation review and physician engagement strategies.
- Demonstrated success in managing and leading teams.
- Understanding of how Behavioral Health quality, regulatory compliance and risk management influence hospital-wide performance and patient safety.
- Knowledge of Behavioral Health regulatory standards (The Joint Commission, CMS, NYS DOH, OMH, OASAS, and the NYSJC), with experience ensuring compliance and readiness for surveys or audits.
- Experience initiating and executing Behavioral Health improvement projects, using data to assess outcomes, and collaborating with multidisciplinary teams to sustain measurable change.
- Understanding of incident reporting, event investigation, and proactive risk assessment from a clinical leadership perspective.
- Strong interpersonal and written/verbal communication skills, with the ability to effectively engage with executive leadership, physicians, and support departments.
- Skilled at using clinical and operational data to inform decisions; ability to interpret dashboards, identify trends, and contribute to strategic quality initiatives.
- Ability to lead change, mentor staff through transitions, and promote a culture of accountability, transparency, and continuous improvement.
The responsibilities and tasks outlined in this job description are not exhaustive and may change as determined by the needs of SBELIH.
Special Notes: Resume/CV should be included with the online application.
- Stony Brook Medicine is a smoke-free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
- All Hospital positions may be subject to changes in pass days and shifts as necessary.
- This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
- This function/position maybe designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook Eastern Long Island and related facilities.
Prior to start date, the selected candidate must meet the following requirements:
- Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Eastern Long Island’s Employee Health Services *
- Complete electronic reference check with a minimum of three (3) professional references.
- Successfully complete a 4 panel drug screen*
- Meet Regulatory Requirements for pre-employment screenings.
- Provide a copy of any required New York State license(s)/certificate(s).
The Human Resources department will be responsible for any fee incurred for examination.
Company Overview:
StaffCo is a Professional Employer Organization, commonly referred to as a PEO, duly organized and registered under the New York Professional Employer Organization law. StaffCo and SUNY have entered into a professional employer agreement under which StaffCo is the employer of Stony Brook Eastern Long Island employees and responsible for all aspects of employment, including hirings, promotions, disciplines, terminations, the day-to-day direction and supervision of work, as well as labor relations and collective bargaining. StaffCo is fully responsible for providing all payroll and human resources services, including the payment of wages, collecting and reporting payroll taxes and maintaining any and all employee benefits. SUNY Stony Brook Hospital is responsible for the operation of the hospital and provision of health care and is the co-employer as is necessary to conduct its responsibilities and for related licensure, regulatory or statutory requirements and obligations.
Given StaffCo’s employment responsibilities, it is deemed the “employer” for employment and labor law purposes. Thus, the employees are private sector employees of StaffCo, not public sector employees of SUNY. The private sector nature of the StaffCo employees has been approved by NYS Civil Service and upheld in a decision by the US National Labor Relations Board.
Stony Brook Medicine is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
Stony Brook Eastern Long Island Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
AVP for Behavioral Health Quality and Regulatory Affairs
Position Summary: The Assistant Vice President (AVP) of Behavioral Health Quality and Regulatory Affairs is a leadership role responsible for overseeing the quality, compliance, and performance improvement efforts across all Behavioral Health services. This position plays a critical role in ensuring the organization meets or exceeds regulatory standards set by the Office of Mental Health (OMH), the Office of Addiction Services and Supports (OASAS), the New York State Justice Center for the Protection of People with Special Needs (NYSJC), and the New Yok State Department of Health (DOH). The AVP serves as a key advisor and subject matter expert in advancing behavioral health care quality, clinical effectiveness, and regulatory compliance. The AVP for Behavioral Health will be responsible for conducting Failure Mode Effects Analysis (FMEA’s) and Root Cause Analyses (RCA’s) including case reviews, deep dives and corrective action plans for all Behavioral Health Services. The AVP has responsibility for Behavioral Health quality improvement and risk reduction strategies.
Job Duties & Essential Functions:
- Support the VP in managing daily operations of the Quality and Regulatory Affairs department to maintain compliance with The Joint Commission, CMS, NYS DOH, OMH, OASAS, NYSJC and other accrediting bodies.
- Coordinate Behavioral Health accreditation readiness activities, regulatory surveys, follow-up corrective actions, and continuous survey preparedness efforts.
- Provide oversight of all Behavioral Health regulatory compliance, ensuring alignment with OMH, OASAS, NYSJC, NIMRS, WISR NYS Web Submission of Investigation Report, AARM NYS Administrative Action Reporting Mechanism and DOH reporting requirements.
- Submit, complete and monitor reporting into the NYSJC, NIMRS, and WISR as required.
- Respond to and manage timely submission of Behavioral Health incidents and sentinel events to required regulatory agencies.
- Provide supporting documentation including investigation reports, case reviews, and timelines to appropriate regulatory agencies in accordance with state and federal regulations.
- Track, trend, and implement policy and process changes in response to Behavioral Health regulatory updates, policy revisions, and documentation standards.
- Lead the development and implementation of Behavioral Health quality improvement initiatives and data-driven performance improvement plans.
- Participate in the investigation and analysis of Behavioral Health safety events, including Root Cause Analyses (RCAs), Failure Mode and Effects Analyses (FMEAs), and near misses.
- Identify and assess Behavioral Health risks related to patient safety, operations, legal liability, and compliance. Track, analyze, and report on risk trends and mitigation strategies.
- Lead Behavioral Health clinical case reviews to evaluate care delivery, identify risks, and recommend improvements.
- Analyze and report Behavioral Health quality metrics and CMS core measures (e.g., eCQMs, Core Measures) to inform program enhancements and risk mitigation strategies.
- Coordinate with leadership on Behavioral Health risk exposure, claim management, and safety event documentation.
- Analyze data from SB Safe and other Behavioral Health quality sources to identify trends and opportunities.
- Monitor SB Safe incidents to ensure timely and accurate follow-up completion as per policy.
- Present SB Safe data to the Incident Review Committee (IRC), identifying trends and opportunities for safety enhancement.
- Manage and oversee the investigation, tracking, and resolution of patient and family complaints and grievances related to Behavioral Health services.
- Ensure grievance responses comply with regulatory requirements, including timeframes and documentation standards.
- Identify trends from Behavioral Health grievance data to inform performance improvement initiatives and report findings to the IRC.
- Provide support to Behavioral Health clinical teams in delivering care that meets standards for safety, quality, and evidence-based practices.
- Serve as a strategic partner to Behavioral Health leadership, Risk Management, Compliance, and other departments to foster a culture of safety, accountability, and excellence.
- Act as a key member of the Behavioral Health Leadership Committee.
- Represent Behavioral Health Quality in meetings, hospital and system committees, workgroups, and during regulatory or accreditation surveys and audits.
- Promote a culture of transparency, accountability, and continuous improvement aligned with SBELIH’s I.C.A.R.E. values.
- Participate in policy review committees and contribute to internal Behavioral Health training efforts, including in-service programs and annual recertification.
- Maintain current knowledge of applicable healthcare laws, regulations, and best practices in Behavioral Health quality, risk, and compliance.
- Perform other related duties as assigned by the Vice President.
Required Experience & Qualifications:
- Bachelor’s degree in nursing or social work required; with Master’s degree within five (5) years from an accredited college or university in Business/Healthcare Administration, Social Work, Nursing Leadership and Administration, Behavioral Health discipline or approved related program.
- Minimum of ten (10) years of combined clinical and administrative experience in a Behavioral Health setting.
- Knowledge of clinical documentation review and physician engagement strategies.
- Demonstrated success in managing and leading teams.
- Understanding of how Behavioral Health quality, regulatory compliance and risk management influence hospital-wide performance and patient safety.
- Knowledge of Behavioral Health regulatory standards (The Joint Commission, CMS, NYS DOH, OMH, OASAS, and the NYSJC), with experience ensuring compliance and readiness for surveys or audits.
- Experience initiating and executing Behavioral Health improvement projects, using data to assess outcomes, and collaborating with multidisciplinary teams to sustain measurable change.
- Understanding of incident reporting, event investigation, and proactive risk assessment from a clinical leadership perspective.
- Strong interpersonal and written/verbal communication skills, with the ability to effectively engage with executive leadership, physicians, and support departments.
- Skilled at using clinical and operational data to inform decisions; ability to interpret dashboards, identify trends, and contribute to strategic quality initiatives.
- Ability to lead change, mentor staff through transitions, and promote a culture of accountability, transparency, and continuous improvement.
The responsibilities and tasks outlined in this job description are not exhaustive and may change as determined by the needs of SBELIH.
Special Notes: Resume/CV should be included with the online application.
- Stony Brook Medicine is a smoke-free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
- All Hospital positions may be subject to changes in pass days and shifts as necessary.
- This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
- This function/position maybe designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook Eastern Long Island and related facilities.
Prior to start date, the selected candidate must meet the following requirements:
- Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Eastern Long Island’s Employee Health Services *
- Complete electronic reference check with a minimum of three (3) professional references.
- Successfully complete a 4 panel drug screen*
- Meet Regulatory Requirements for pre-employment screenings.
- Provide a copy of any required New York State license(s)/certificate(s).
The Human Resources department will be responsible for any fee incurred for examination.
Company Overview:
StaffCo is a Professional Employer Organization, commonly referred to as a PEO, duly organized and registered under the New York Professional Employer Organization law. StaffCo and SUNY have entered into a professional employer agreement under which StaffCo is the employer of Stony Brook Eastern Long Island employees and responsible for all aspects of employment, including hirings, promotions, disciplines, terminations, the day-to-day direction and supervision of work, as well as labor relations and collective bargaining. StaffCo is fully responsible for providing all payroll and human resources services, including the payment of wages, collecting and reporting payroll taxes and maintaining any and all employee benefits. SUNY Stony Brook Hospital is responsible for the operation of the hospital and provision of health care and is the co-employer as is necessary to conduct its responsibilities and for related licensure, regulatory or statutory requirements and obligations.
Given StaffCo’s employment responsibilities, it is deemed the “employer” for employment and labor law purposes. Thus, the employees are private sector employees of StaffCo, not public sector employees of SUNY. The private sector nature of the StaffCo employees has been approved by NYS Civil Service and upheld in a decision by the US National Labor Relations Board.
Stony Brook Medicine is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
Stony Brook Eastern Long Island Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
See All 28 Regulatory Affairs Analyst Jobs in New York
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Find JobsRegulatory Affairs Analyst Jobs by City in New York
Where New York roles are concentrated, by current openings.
Regulatory Affairs Analyst Job Market in New York
A snapshot from current New York openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Banking & Financial Services
- Healthcare & Medical Services
- Biotechnology & Pharmaceuticals
- Education
- Insurance
What New York Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs across New York.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field required
- Direct experience preparing FDA regulatory submissions including INDs, NDAs, or 510(k)s
- Strong knowledge of FDA regulations, ICH guidelines, and applicable federal requirements
- Regulatory Affairs Certification (RAC) from RAPS preferred for mid-level and senior roles
- Proficiency with electronic submission platforms such as eCTD authoring tools
- Excellent written communication skills for drafting regulatory documents and correspondence
Regulatory Affairs Analyst Jobs in New York: Frequently Asked Questions
How do you become a regulatory affairs analyst in New York?
Most regulatory affairs analyst positions in New York require a bachelor's degree in a life science, pharmacy, engineering, or related field, with many employers preferring a master's or advanced degree for senior roles. New York does not require a state-issued license for regulatory affairs analysts, but earning the Regulatory Affairs Certification from RAPS strengthens your candidacy considerably. Large pharmaceutical and medical device employers in the New York City and Hudson Valley markets typically want candidates who have completed internships or rotational programs with exposure to FDA submissions and compliance.
Which companies hire regulatory affairs analysts in New York?
New York regulatory affairs analyst roles are posted by Regeneron, Oscar Health, and Butterfly Network and others right now, based on current listings on Migrate Mate as of July 2026. New York's density of pharmaceutical headquarters, global biotech firms, and large hospital and health system networks means the market stays active well beyond the most prominent names.
Which New York cities have the most regulatory affairs analyst jobs?
New York, Tarrytown, and Jamaica account for the largest share of regulatory affairs analyst openings in New York. New York City dominates because of its concentration of pharmaceutical and medical device corporate headquarters, while areas outside the city draw openings from major research campuses and manufacturing sites where on-site regulatory teams are essential.
Are there remote regulatory affairs analyst jobs in New York?
Yes, and more than most fields. About 50% of regulatory affairs analyst openings tied to New York are remote or hybrid as of July 2026, reflecting the desk-based and document-driven nature of much of the work. Regulatory writing, submissions review, and compliance analysis are the functions most frequently offered as fully remote positions, while roles tied to manufacturing sites or laboratory oversight tend to remain on-site.
How can I get hired as a regulatory affairs analyst in New York with little or no experience?
The most realistic entry path is a regulatory affairs internship or rotational associate program at one of New York's larger pharmaceutical or medical device employers, where Pfizer, Regeneron, and similar firms regularly bring on new graduates through structured programs. Candidates moving from adjacent roles such as quality assurance associate, clinical data coordinator, or scientific writer often transition successfully because those positions build familiarity with FDA documentation and compliance processes. Completing a RAC exam prep course or earning a graduate certificate in regulatory affairs from a New York university adds measurable credibility before your first dedicated regulatory role.
Where can I find and apply to regulatory affairs analyst jobs in New York?
You can find and apply to regulatory affairs analyst jobs in New York on Migrate Mate, which lists current New York openings updated in real time. Search the listings to find roles that match your experience, specialization, and location preference, then apply directly to the ones that fit.
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