Top 199 Regulatory specialist Jobs in New Haven Ct

Regulatory Submissions Specialist
Celldex Therapeutics —New Haven, CT
- $76,374 - $99,188 a year
- Microsoft Word
- Mid-level
- Quality control
- Paid holidays
- Health insurance
5d
Patient Relations Specialist
Yale New Haven Health —New Haven, CT
- Full-time
- Nursing
- Hospital
- Computer literacy
Hybrid Affordable Housing Compliance Specialist
CS American Management —Hamden, CT
- $65,000 - $70,000 a year
- Weekends as needed
- Hybrid work
- Background check
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Quick Apply
6d
General Dentist
Mondovi Dental —Bristol, CT
- From $200,000 a year
- Monday to Friday
- Private practice
- CPR Certification
- Dental office
- Health savings account
- Disability insurance
Physician Assistant - Wound Care - Part Time
Connecticut Orthopaedic Specialists Pc —Fairfield, CT
- Part-time
- Acute care
- Mid-level
- Wound Care
- Free parking
- Paid holidays
Quick Apply
Extraction Specialist
Theraplant —Watertown, CT
- $20 an hour
- Full-time
- Ability to walk for extended periods
- Computer literacy
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Pediatric Speech Language Pathologist (SLP) in New Haven, CT
Sunbelt Staffing —New Haven, CT
- $40 - $60 an hour
- Choose your own hours
- School experience
- Mid-level
- Pediatrics
Quick Apply
RN Clinical Research
Hartford HealthCare Corp. —Fairfield, CT
- Full-time
- Nursing
- Microsoft Access
- Mid-level
Quick Apply
Therapeutic Educational and Recreational Specialist
Oak Hill —Waterbury, CT
- Full-time
- Mid-level
- Master's degree
- Organizational skills
- Paid training
- Health savings account
Quick Apply
Medical Assistant - Full Time - East Region Float Position - Signon Bonus!
Moses / Weitzman Health System —Middletown, CT
- $21 an hour
- Full-time
- Bilingual
- CPR Certification
- Vital signs
- Health insurance
Safety Inspector
Actalent —Naugatuck, CT
- $20 - $25 an hour
- Contract
- Construction site
- Mid-level
- First Aid Certification
- Commuter assistance
- Health savings account
Quick Apply
3d
Medical Billing & Accounts Receivable Administrator
Vein Institute —Newtown, CT
- $42,000 - $50,000 a year
- Full-time
- Background check
- HIPAA
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
11d
Center for Key Populations - LPN - Meriden, New Britain, Middletown - 32 hours a week
Moses / Weitzman Health System —Meriden, CT
- Part-time
- Bilingual
- CPR Certification
- Nursing
LPN - Primary Care - CHC of Meriden - Saturday and Sundays
Moses / Weitzman Health System —Meriden, CT
- Part-time
- Bilingual
- CPR Certification
- Nursing
Dental Billing Specialist (2 yrs Exp at least)
Constant Dental Care —Southington, CT
- $20 - $24 an hour
- Part-time
- Background check
- Dental office
- Medical office experience
- Employee discount
- Professional development assistance
Quick Apply
2d
Physical Therapist - Clinical Specialist - FT
Tender Touch Rehab Services —Naugatuck, CT
- $48 - $55 an hour
- Full-time
- Skilled nursing facility
- Bachelor of Science
- Physical & Rehabilitation Medicine
- Continuing education credits
- Health insurance
Quick Apply
Lead Clinician (LCSW) - Adult
Rushford —Meriden, CT
- Full-time
- Management
- Psychiatry
- Addiction Medicine
- Paid holidays
- Health insurance
Quick Apply
2d
Clinician (LCSW, LPC, LMFT, LADC) - Adult IOP
Rushford —Meriden, CT
- Full-time
- LMFT
- Computer literacy
- Licensed Clinical Social Worker
- Paid holidays
- Health insurance
Quick Apply
4d
Health Center Training Specialist
Planned Parenthood —New Haven, CT
- $43,322 - $72,204 a year
- Full-time
- Hybrid work
- Spanish
- Medical office experience
- HIPAA
- Wellness program
- Paid parental leave
Senior Regulatory Affairs Specialist
Yale University —New Haven, CT
- $82,000 - $131,500 a year
- Full-time
- Remote
- Background check
- Microsoft Excel
- Microsoft Outlook
5d

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regulatory specialist jobs near new haven ct

Regulatory Submissions Specialist

Celldex Therapeutics -
New Haven, CT

Apply Now

Job Details

$76,374 - $99,188 a year
5 days ago

Benefits

Paid holidays
Health insurance
401(k)

Qualifications

Microsoft Word
FDA submissions
Records disposition policies
System troubleshooting
Data Retention (Data management)
Digital archiving
Word embeddings
E-filing platforms
Mid-level
Investigational new drug (IND) applications
EndNote
Documentation tools
Quality control
Compliance documentation
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Document quality checks
Technical writing quality assurance
Clinical research documentation
Content review
Communication skills
Adobe Acrobat
Editing

Full Job Description

Overview:

The Regulatory Submissions Specialist is responsible for the paper and electronic compilation and submission of Regulatory submissions and maintaining submission information in the proper RA repositories. The Regulatory Submissions Specialist will assist the regulatory affairs personnel for ensuring all publishing and QC processes are followed and all submission requirements are met prior to dispatching or submitting to the Health Authority.

Responsibilities:

Work with regulatory staff to prepare, assemble, process, format, quality control, publish, submit and archive submissions (e.g., IND, CTA, BLA, Amendments, Supplements, Annual Reports, IMPD and Briefing Documents) to US, CA and other international health authorities using advanced electronic publishing software (eCTD Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions.
Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness and compliance
Generate regulatory submissions on time and in compliance with Company standards and regional regulatory agency regulations.
Assist with troubleshooting system issues
Assist with developing best practices in submission publishing and enhancing process efficiency
Archive documents according to archiving and document retention regulations

Qualifications:

A minimum of 1 year of regulatory affairs electronic publishing experience preferred; other relevant experience with clinical trial documentation and electronic systems will be considered.
Experience with IND, CTA, BLA submissions
eCTD paperless submission experience using agency electronic submission’s gateway (ESG)
Experience preparing and submitting regulatory filings using Veeva RIMS
Proficient in MS Word formatting large documents and using template
EndNotes software experience a plus
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
Demonstrated ability in analytical reasoning and critical thinking skills
Ability to work in a fast paced environment and to handle multiple tasks
Capability to contribute to a team environment
Strong communication skills
The ability to work independently and as part of a team
Knowledge of publishing tools/systems in Pharma industry

Compensation Statement: The expected base salary for this position is: $76374.00 to $99188.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Apply Now

Refine Your Search

regulatory specialist jobs in new haven ct

Regulatory Submissions Specialist

Patient Relations Specialist

Hybrid Affordable Housing Compliance Specialist

General Dentist

Physician Assistant - Wound Care - Part Time

Extraction Specialist

Pediatric Speech Language Pathologist (SLP) in New Haven, CT

RN Clinical Research

Therapeutic Educational and Recreational Specialist

Medical Assistant - Full Time - East Region Float Position - Signon Bonus!

Safety Inspector

Medical Billing & Accounts Receivable Administrator

Center for Key Populations - LPN - Meriden, New Britain, Middletown - 32 hours a week

LPN - Primary Care - CHC of Meriden - Saturday and Sundays

Dental Billing Specialist (2 yrs Exp at least)

Physical Therapist - Clinical Specialist - FT

Lead Clinician (LCSW) - Adult

Clinician (LCSW, LPC, LMFT, LADC) - Adult IOP

Health Center Training Specialist

Senior Regulatory Affairs Specialist

I want to receive the latest job alert for regulatory specialist in new haven ct

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