Top 33 Regulatory affairs manager Jobs in Bridgewater Nj

Manager, Regulatory Affairs
MTF Biologics —Edison, NJ
- $99,000 - $125,000 a year
- Full-time
- Management
- 5 years
- Bachelor's degree
Quick Apply
Regulatory Affairs Project Manager (173814)
Colgate-Palmolive —Piscataway, NJ
- $124,000 - $174,000 a year
- Hybrid work
- Master's degree
- Bachelor's degree
- Travel
- Profit sharing
- Paid parental leave
Senior Regulatory Affairs Program Manager
ImmunityBio —Summit, NJ
- $170,000 - $187,000 a year
- Full-time
- 6 years
- Office
- Analysis skills
- AD&D insurance
- Disability insurance
Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)
Essenlix —Monmouth Junction, NJ
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Health insurance
- 401(k)
Quick Apply
Manager, REMS Center of Excellence (Remote)
Sandoz —Princeton, NJ
- $91,400 - $169,700 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Senior Manager, Regulatory Affairs - OTC
Haleon —Warren, NJ
- $152,620 - $209,852 a year
- Full-time
- Hybrid work
- 7 years
- Office
- Bachelor's degree
- Paid parental leave
- Health insurance
Manager, Regulatory Affairs - Cosmetics (Global)
Church & Dwight —Princeton, NJ
- $110,900 - $157,900 a year
- Full-time
- Hybrid work
- 8 years
- Bachelor's degree
- Continuous improvement
- Profit sharing
- Paid parental leave
Regulatory Affairs Manager
TRIPLECOM —New Brunswick, NJ
- Office
- 3 years
- Bachelor's degree
Regulatory Affairs Program Manager
ImmunityBio —Summit, NJ
- $141,300 - $157,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
- AD&D insurance
- Disability insurance
RA Manager
Sandoz —Princeton, NJ
- $114,100 - $211,900 a year
- Full-time
- Hybrid work
- Writing skills
- English
- Office
- Health insurance
- Dental insurance
Sr. Manager, Medical Affairs Operations
Taiho Oncology, Inc. —Princeton, NJ
- $186,150 - $219,000 a year
- Full-time
- Hybrid work
- 5 years
- Finance
- Master's degree
- Paid time off
- Parental leave
Quick Apply
Senior Manager, Regulatory Affairs Advertising and Promotion
Sanofi —Morristown, NJ
- $122,250.00 - $176,583.33 a year
- Writing skills
- Office
- Bachelor's degree
- Parental leave
Manager, Quality Assurance & Regulatory Affairs
PerkinElmer —Kenilworth, NJ
- Full-time
- Sales
- Data analysis skills
- Driver's License
Associate Director, Commercial Regulatory Affairs
Bristol-Myers Squibb —Princeton, NJ
- $173,350 - $210,058 a year
- Email
- Hybrid work
- 5 years
- Bachelor of Science
- Office
- Paid holidays
- Disability insurance
4d
Manager, MeRL Review
Genmab —Princeton, NJ
- $113,680 - $170,520 a year
- Online Application
- Bachelor's degree
- Organizational skills
- Training & development
- Commuter assistance
- Paid parental leave
Senior Manager, Medical, Regulatory and Legal (MeRL)
Genmab —Princeton, NJ
- $132,480 - $198,720 a year
- Online Application
- 7 years
- Bachelor's degree
- Organizational skills
- Commuter assistance
- Paid parental leave
Senior Director, Regulatory Operations
Acadia Pharmaceuticals Inc. —Princeton, NJ
- $220,600 - $275,700 a year
- Hybrid work
- 11+ years
- Office
- Bachelor's degree
- Paid parental leave
- Employee stock purchase plan
Senior Patient Affordability Operations Manager
Novo Nordisk —Plainsboro, NJ
- $120,000 - $223,000 a year
- Office
- Analysis skills
- Bachelor's degree
- Disability insurance
- Health insurance
Specialist, NWM Sales Quality
NRG —Princeton, NJ
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quick Apply
8d
Director, Companion Diagnostic Program Manager
Genmab —Princeton, NJ
- $194,560 - $291,840 a year
- Online Application
- Hybrid work
- 7 years
- Bachelor's degree
- Contracts
- Commuter assistance
- Paid parental leave

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Manager, Regulatory Affairs

MTF Biologics -
Edison, NJ

Quick Apply

Job Details

Full-time
$99,000 - $125,000 a year

Qualifications

Regulatory inspections
ISO certification process
Staff supervision
Management
GMP
Biomedical regulatory compliance

Full Job Description

Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Ability to travel up to 20% of time to MTF locations and to suppliers as required

Monday through Friday 8:15am to 4:30pm

Salary Range : $99,000- $125,000/yr.

Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance. Also performs active management and observations of staff for compliance with regulations and process efficiencies.
Assist in managing the budget for Regulatory Affairs department, including salaries, benefits, external vendors/consultants, supplies, services and internal expenses. Responsible for formulating/submitting budgets and managing to expense within budget requirements. Tracks monthly "budget to actual" performance.
Oversee and assist in the preparation, submission, and maintenance of U.S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets).
Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 certifications.
Participates in the development of regulatory strategies and pathway to support the regulatory designation of new products and tissues.
Serve as a primary regulatory contact during inspections and audits and lead regulatory intelligence activities.
Communicates and coordinates with VP and MTF senior management and other department heads on regulatory issues and regulatory strategies which may impact MTF's ability to fulfill its mission.
Communicates with federal/state regulatory agencies, international government and notified bodies, and AATB related to applicable new or revised regulations and standards
Assist on special projects and performs additional duties as assigned.

Bachelor's degree in a scientific or related field, or a combination of education and equivalent work experience
7+ Years of overall experience
5 Years of Managerial experience
5 Years or Human tissue or medical device manufacturing
Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma Must exhibit people management, effective communication skills
Attention to detail, critical thinking, problem-solving, and organizational skills
Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies
Ability to travel up to 20% of time to MTF locations and to suppliers as required

Quick Apply

Refine Your Search

regulatory affairs manager jobs in bridgewater nj

Manager, Regulatory Affairs

Regulatory Affairs Project Manager (173814)

Senior Regulatory Affairs Program Manager

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

Manager, REMS Center of Excellence (Remote)

Senior Manager, Regulatory Affairs - OTC

Manager, Regulatory Affairs - Cosmetics (Global)

Regulatory Affairs Manager

Regulatory Affairs Program Manager

RA Manager

Sr. Manager, Medical Affairs Operations

Senior Manager, Regulatory Affairs Advertising and Promotion

Manager, Quality Assurance & Regulatory Affairs

Associate Director, Commercial Regulatory Affairs

Manager, MeRL Review

Senior Manager, Medical, Regulatory and Legal (MeRL)

Senior Director, Regulatory Operations

Senior Patient Affordability Operations Manager

Specialist, NWM Sales Quality

Director, Companion Diagnostic Program Manager

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