Regulatory Affairs Specialist Jobs in Morrisville, PA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Dayton, NJ (20 miles from Morrisville, PA)
- 2 days ago
- Dayton, NJ (20 miles from Morrisville, PA)
- 2 days ago
The Team: The Import Export Team plays a crucial role in ensuring our merchandise and non-merchandise arrive safely and efficiently while adhering to all federal regulations of import/export. Our...
- Trenton, NJ (3 miles from Morrisville, PA)
- 3 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 3 days ago
Job Order Number: DE9405993 Job Title: Trade Compliance Analyst Company: Otsuka America Pharmaceutical Inc. Location: Trenton, NJ Salary: Education: Less Than High School Experience: None Hours:...
Food Safety & Regulatory Compliance Specialist
- Cranbury, NJ (17 miles from Morrisville, PA)
- 4 days ago
- Cranbury, NJ (17 miles from Morrisville, PA)
- 4 days ago
Support the maintenance and review of key food safety and quality systems, including pest control, sanitation, GMP, and internal auditing....
Remote IT Quality Assurance and Compliance, Analyst
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 6 days ago
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 6 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Cherry Hill , New Jersey Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and...
Remote WorkMarketing and Product Compliance Analyst
- Trenton, NJ (3 miles from Morrisville, PA)
- 6 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 6 days ago
Job Order Number: DE9400799 Job Title: Marketing and Product Compliance Analyst Company: Zoom Location: Trenton, NJ Salary: Education: Less Than High School Experience: None Hours: Duration: Full...
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
Open to:?General Public? Work Week: NE (35-hour) Work Week Salary:?$78,024.71 - $111,000.80? Opening Date: 2/4/2025 Closing Date: 2/25/2025 Existing Vacancies:?3 Program/Location?Department of...
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Trenton, NJ (3 miles from Morrisville, PA)
- 11 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 11 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote Work- Trenton, NJ (3 miles from Morrisville, PA)
- 15 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 15 days ago
Responsible for assisting the Regulatory Team with the processes of maintenance and registration of new products and state wholesaler licenses as required from the FDA (Food and Drug...
- Princeton, NJ (14 miles from Morrisville, PA)
- 20 days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 20 days ago
Prepare and maintain regulatory documents in eCTD format for reference and easy retrieval and update the standards in accordance with current FDA regulations, checking for expired/outdated products....
Renewable Natural Gas Regulatory Compliance Analyst
- Jackson, NJ (24 miles from Morrisville, PA)
- 22 days ago
- Jackson, NJ (24 miles from Morrisville, PA)
- 22 days ago
Renewable Natural Gas Regulatory Compliance Analyst Suburban Propane Location Jackson Twp Posted date 9 hours ago Minimum level N/A Job type Full-time Job category Other Over When you join...
International Regulatory Compliance Specialist
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 45+ days ago
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 45+ days ago
One of our food & beverage manufacturing clients is seeking an International Regulatory Compliance Specialist to join their team on site in Mount Laurel, NJ. This individual is going to be helping...
Compliance Analyst- Originations
- Fort Washington, PA (21 miles from Morrisville, PA)
- 60+ days ago
- Fort Washington, PA (21 miles from Morrisville, PA)
- 60+ days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Demographic Data for Morrisville, PA
Moving to Morrisville, PA? Find some basic demographic data about Morrisville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morrisville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morrisville, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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