Top 29 Regulatory affairs associate Jobs in Saddle Brook Nj

Clinical Research Associate
Rutgers University —Newark, NJ
- $68,147 a year
- Full-time
- HIPAA
- Mid-level
- Office
- Paid holidays
- Dental insurance
Clinical Project Associate
OrganOx —Madison, NJ
- $60,000 - $75,000 a year
- Full-time
- Remote
- Microsoft Word
- Nursing
- Writing skills
- Paid holidays
- Disability insurance
Quick Apply
Senior Associate, Regulatory Operations
Breckenridge Pharmaceutical Inc —Berkeley Heights, NJ
- $115,000 - $135,000 a year
- Full-time
- Remote
- 5 years
- Office
- Databases
- Health insurance
- Dental insurance
Quick Apply
Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote
Merck —Rahway, NJ
- $96,200 - $151,400 a year
- Full-time
- Remote
- English
- Mid-level
- Microsoft Office
- Paid holidays
- Health insurance
Clinical Research Coordinator
Hackensack Meridian Health —Hackensack, NJ
- From $41,891.20 a year
- Part-time
- Customer service
- Bachelor of Science
- Mid-level
- Health insurance
- Dental insurance
Sr Associate Regulatory Affairs
Breckenridge Pharmaceutical Inc —Berkeley Heights, NJ
- $88,000 - $125,000 a year
- Full-time
- Microsoft Word
- 5 years
- Office
- Health insurance
Quick Apply
Regulatory Affairs Senior Associate
electroCore Inc —Rockaway, NJ
- Full-time
- Office
- Travel
- Mentoring
Sr. Specialist, Regulatory Affairs
Metagenics —Jersey City, NJ
- $125,500 - $140,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Office
- Master's degree
- Health savings account
- AD&D insurance
Principal, RA Specialist
Integrated DNA Technologies (IDT) —New York, NY
- $110,000 - $135,000 a year
- Full-time
- Remote
- Research
- Analysis skills
- Project management
- Health insurance
- Dental insurance
Regulatory Affairs Strategist, Globalization (Americas - US, Canada, LATAM)
BD —Franklin Lakes, NJ
- $135,500 - $216,800 a year
- Engineering
- Office
- Master's degree
- Wellness program
- Commuter assistance
Regulatory Affairs Strategist, Globalization (EMEA - Europe, META)
BD —Franklin Lakes, NJ
- $137,500 - $220,100 a year
- Engineering
- Office
- Master's degree
- Wellness program
- Commuter assistance
Senior Associate, Team Lead Compliance
New York Life —New York, NY
- $100,000 - $143,000 a year
- Hybrid work
- 5 years
- Bachelor's degree
- Senior level
- Loan repayment program
- Disability insurance
Associate Manager, Regulatory Advertising & Promotion
Regeneron —Sleepy Hollow, NY
- $109,900 - $179,300 a year
- Bachelor of Science
- Mid-level
- Office
- Health insurance
- Dental insurance
Associate Director, Corporate Compliance
Oscar Health —New York, NY
- $149,040 - $195,615 a year
- Hybrid work
- 5 years
- HIPAA
- Office
- Paid parental leave
- Paid holidays
Quick Apply
Senior Trauma Clinical Data Coordinator - Full Time - Day
Hackensack Meridian Health —Hackensack, NJ
- $35.17 an hour
- Full-time
- Bachelor of Science
- High school diploma or GED
- Senior level
- Health insurance
- Dental insurance
Senior Clinical Research Associate - Cardiovascular Medical Device
T45 Labs —New York, NY
- $113,000 - $153,000 a year
- Email
- Remote
- Nursing
- 7 years
- Bachelor's degree
Quick Apply
5d
Associate Director, CMC Regulatory Affairs
NS Pharma —Paramus, NJ
- $170,000 - $190,000 a year
- Hybrid work
- English
- Office
- 8 years
- Paid parental leave
- Health savings account
Manager, Regulatory Affairs Packaging Compliance
Bath & Body Works —New York, NY
- $107,000 - $182,600 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Mentoring
- Store discount
- Paid parental leave
Associate Director, CMC Regulatory Affairs
NS Pharma Inc —Paramus, NJ
- $170,000 - $190,000 a year
- Hybrid work
- English
- Office
- 8 years
- Paid parental leave
- Health savings account
Quick Apply
Associate Director, 340B Strategy & Innovation
AbbVie —Florham Park, NJ
- $141,500 - $268,500 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Conflict management
- Paid holidays
- Health insurance

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Clinical Research Associate

Rutgers University -
Newark, NJ

Apply Now

Job Details

Full-time
$68,147 a year

Benefits

Paid holidays
Dental insurance
Employee discount
Life insurance

Qualifications

Informed consent
Master's degree
Clinical research compliance
Productivity software

Full Job Description

Position Details

Position Information

Recruitment/Posting Title

Clinical Research Associate

Job Category

Staff & Executive - Healthcare

Department

NJMS - Medicine Infectious Dis

Overview

New Jersey’s academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University–New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research.

Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers.

Our clinical and academic facilities are located throughout the state—at Rutgers University–New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark’s University Hospital in Newark, and other affiliates.

Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives.

Posting Summary

Rutgers, The State University of New Jersey, is seeking a Clinical Research Associate in the Department of Medicine within the New Jersey Medical School (NJMS).

The primary purpose of the Clinical Research Associate position is to serve as a member of a multidisciplinary research team, utilizing specialized knowledge, skills, and competencies in human subjects protection, regulatory guidance and coordination with Institutional Review Board approval guidelines. Works with study coordinators in ensuring regulatory compliance in research protocols. Organizes and coordinates all regulatory filings and communications with regulators and sponsors.

Among the key duties of this position are the following:

Provides overall study regulatory coordination and protocol compliance per FDA, GCP guidelines, OHRP, HIPAA, Conflict of Interest, IRB and institutional guidelines, and standard operating procedures set forth by Rutgers, the Division and Study Sponsor(s).
Assists investigators and coordinators with development of IRB submissions, consent forms and other documents for review by regulatory officials/offices.
Assists investigators and research staff in preparation of regulatory and compliance documentation required for grant submissions, including human subjects sections, protocol summaries, and supporting materials to ensure alignment with sponsor and institutional requirements.
Leads coordination and development of regulatory and compliance components for sponsor progress reports, including RPPR submissions, by tracking required documentation, verifying regulatory status, and assembling materials in collaboration with investigators and research staff..
Organizes the development of protocol-specific regulatory binders, communications with sponsor representatives and collaborator regulatory communications, protocol and ICF version control.

FLSA

Exempt

Grade

24S

Salary Details

Minimum Salary

68147.000

Mid Range Salary

81720.000

Maximum Salary

96989.000

Offer Information

The final salary offer may be determined by several factors, including, but not limited to, the candidate’s qualifications, experience, and expertise, and availability of department or grant funds to support the position. We also take into consideration market benchmarks, if and when appropriate, and internal equity to ensure fair compensation relative to the university’s broader compensation structure. We are committed to offering competitive and flexible compensation packages to attract and retain top talent.

Benefits

Rutgers provides a comprehensive benefits package to eligible employees. The specific benefits vary based on the position and may include:

Medical, prescription drug, and dental coverage
Paid vacation, holidays, and various leave programs
Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options
Employee and dependent educational benefits (when applicable)
Life insurance coverage
Employee discount programs

Position Status

Full Time

Working Hours

Standard Hours

37.50

Daily Work Shift

Work Arrangement

Consistent with the current application of Rutgers Policy 60.3.22 or the applicable provisions of relevant collective negotiations agreements, this position requires a fully on-site work arrangement and may be eligible for a compressed workweek or a flex workday schedule. Flexible work arrangements are not permanent, are subject to change or discontinuation, and contingent on the employee receiving approval in the FlexWork@RU Application System.

Union Description

HPAE 5094

Payroll Designation

PeopleSoft

Seniority Unit

Terms of Appointment

Staff - 12 month

Position Pension Eligibility

ABP

Qualifications

Minimum Education and Experience

Master’s Degree in a related field plus three (3) years of research experience, two (2) of which shall have included university level regulatory affairs.

Certifications/Licenses

Required Knowledge, Skills, and Abilities

Strong regulatory research specific knowledge base (IRB, informed consent, human subjects protection).
Solid knowledge of computer software programs (Microsoft Office, databases, etc.).
Demonstrated ability to maximize resources on a continued basis.
Must be detail oriented.
Must have excellent organization, communication, and interpersonal skills.
Must hold self accountable to high standards of professional excellent.

Preferred Qualifications

Preferred experience in a research university setting.

Equipment Utilized

Physical Demands and Work Environment

PHYSICAL DEMANDS:

Standing, sitting, walking, talking and hearing.
No special vision requirements.
Must be able to lift or exert force up to twenty-five (25) pounds.

WORK ENVIRONMENT:

Clinical and office environment.
Moderate noise.
Working with patients.

Special Conditions

Posting Details

Posting Number

26ST0601

Posting Open Date

Special Instructions to Applicants

Regional Campus

Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus

Newark (RBHS)

City

Newark

State

Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.

Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we encourage all qualified applicants to apply. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement

Supplemental Questions

Required fields are indicated with an asterisk (*).

Do you possess a Master’s Degree in a related field and have three (3) years of research experience; two (2) of which shall have included university level regulatory affairs?

Do you have experience in a research university setting?
- Yes
- No

Applicant Documents

Required Documents

Resume/CV

Optional Documents

Cover Letter/Letter of Application

Certifications/Licenses

Apply Now

Refine Your Search

regulatory affairs associate jobs in saddle brook nj

Clinical Research Associate

Clinical Project Associate

Senior Associate, Regulatory Operations

Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote

Clinical Research Coordinator

Sr Associate Regulatory Affairs

Regulatory Affairs Senior Associate

Sr. Specialist, Regulatory Affairs

Principal, RA Specialist

Regulatory Affairs Strategist, Globalization (Americas - US, Canada, LATAM)

Regulatory Affairs Strategist, Globalization (EMEA - Europe, META)

Senior Associate, Team Lead Compliance

Associate Manager, Regulatory Advertising & Promotion

Associate Director, Corporate Compliance

Senior Trauma Clinical Data Coordinator - Full Time - Day

Senior Clinical Research Associate - Cardiovascular Medical Device

Associate Director, CMC Regulatory Affairs

Manager, Regulatory Affairs Packaging Compliance

Associate Director, CMC Regulatory Affairs

Associate Director, 340B Strategy & Innovation

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