Regulatory Affairs Specialist Jobs in Pipersville, 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.
Regulatory Compliance Specialist
- Blue Bell, PA (20 miles from Pipersville, PA)
- 7 hours ago
- Blue Bell, PA (20 miles from Pipersville, PA)
- 7 hours ago
Internal Reference Number: R1044888 Summary The Regulatory Compliance Specialist position is a part of Companion Life's Regulatory and Market Conduct Team within the Compliance Department. In this...
- Princeton, NJ (24 miles from Pipersville, PA)
- 9 hours ago
- Princeton, NJ (24 miles from Pipersville, PA)
- 9 hours ago
Regulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Regulatory Affairs, Specialist Labeling
- Princeton, NJ (24 miles from Pipersville, PA)
- 9 hours ago
- Princeton, NJ (24 miles from Pipersville, PA)
- 9 hours ago
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and...
Compliance Analyst - Operations
- Princeton, NJ (24 miles from Pipersville, PA)
- 20 hours ago
- Princeton, NJ (24 miles from Pipersville, PA)
- 20 hours ago
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Senior Risk & Compliance Analyst
- Trenton, NJ (24 miles from Pipersville, PA)
- 8 days ago
- Trenton, NJ (24 miles from Pipersville, PA)
- 8 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Public Sector Compliance Analyst
- Trenton, NJ (24 miles from Pipersville, PA)
- 13 days ago
- Trenton, NJ (24 miles from Pipersville, PA)
- 13 days ago
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkSr. Specialist, Regulatory Affairs
- North Wales, PA (17 miles from Pipersville, PA)
- 15 days ago
- North Wales, PA (17 miles from Pipersville, PA)
- 15 days ago
regulations, preferred Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage...
Regulatory Compliance Specialist II
- Allentown, PA (22 miles from Pipersville, PA)
- 16 days ago
- Allentown, PA (22 miles from Pipersville, PA)
- 16 days ago
Regulatory Compliance Specialist II Allentown, Pennsylvania, United States | Posted: 6/24/2025 Indotronix is an Equal Opportunity Employer Let Us Do the Heavy Lifting! Upload your resume and we'll...
Compliance Analyst- HMDA Originations
- Fort Washington, PA (21 miles from Pipersville, PA)
- 16 days ago
- Fort Washington, PA (21 miles from Pipersville, PA)
- 16 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...
Senior Compliance Analyst (Interpretation and Advising) - Remote
- Trenton, NJ (24 miles from Pipersville, PA)
- 28 days ago
- Trenton, NJ (24 miles from Pipersville, PA)
- 28 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...
Remote WorkSr Compliance Analyst- Originations
- Fort Washington, PA (21 miles from Pipersville, PA)
- 29 days ago
- Fort Washington, PA (21 miles from Pipersville, PA)
- 29 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...
Senior Regulatory Compliance Analyst
- Princeton, NJ (24 miles from Pipersville, PA)
- 30+ days ago
- Princeton, NJ (24 miles from Pipersville, PA)
- 30+ days ago
Posting Details Posted: June 12, 2025 Full-Time Remote Locations Showing 1 location Nationwide Opportunity- Remote Princeton, NJ 08540, USA Job Details Description Location: Remote near any...
Regulatory Affairs Specialist - Post Market
- Trenton, NJ (24 miles from Pipersville, PA)
- 30+ days ago
- Trenton, NJ (24 miles from Pipersville, PA)
- 30+ days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkRegulatory Compliance Specialist in Bethlehem,PA,US
- Bethlehem, PA (16 miles from Pipersville, PA)
- 30+ days ago
- Bethlehem, PA (16 miles from Pipersville, PA)
- 30+ days ago
Support third-party regulatory, customer, and internal audits by organizing, maintaining, and presenting necessary documentation....
US - Regulatory Affairs Associate II
- Princeton, NJ (24 miles from Pipersville, PA)
- 45+ days ago
- Princeton, NJ (24 miles from Pipersville, PA)
- 45+ days ago
Job Purpose Responsible for supporting Sandoz business registration process, for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions...
Demographic Data for Pipersville, PA
Moving to Pipersville, PA? Find some basic demographic data about Pipersville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pipersville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pipersville, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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