Director of Regulatory Affairs Jobs in Newtown, 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.
Director of Regulatory Affairs, Academic Affairs Office, Penn Law
- Philadelphia, PA (24 miles from Newtown, PA)
- 9 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 9 days ago
Director of Regulatory Affairs, Academic Affairs Office, Penn Law University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education...
Associate Director Regulatory Affairs (Immune Health Institute) University of Pennsylvania
- Philadelphia, PA (24 miles from Newtown, PA)
- 14 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 14 days ago
Posted Job Title Associate Director Regulatory Affairs (Immune Health Institute) Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary he Associate Director of Regulatory...
Associate Director Regulatory Affairs (Immune Health Institute)
- Philadelphia, PA (24 miles from Newtown, PA)
- 14 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 14 days ago
Posted Job Title Associate Director Regulatory Affairs (Immune Health Institute) Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary he Associate Director of Regulatory...
Manager, Regulatory Affairs Strategy
- Princeton, NJ (17 miles from Newtown, PA)
- 20 days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 20 days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Regulatory Affairs Manager, North America (Bilingual)
- Philadelphia, PA (24 miles from Newtown, PA)
- 20 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 20 days ago
This position reports to the Global Director of Regulatory Affairs and Sustainability Compliance. Qualified candidates residing in Philadelphia, PA preferred due to business needs....
Regulatory Affairs Manager, North America
- Philadelphia, PA (24 miles from Newtown, PA)
- 21 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 21 days ago
This position reports to the Global Director of Regulatory Affairs and Sustainability Compliance. Qualified candidates residing in Philadelphia, PA preferred due to business needs....
Director of Regulatory Affairs (Newtown, PA) --Manage and direct regulatory affairs and compliance and serve as principal regulatory contact with the U.S....
Director, Regulatory Affairs (US)
- Philadelphia, PA (24 miles from Newtown, PA)
- 25 days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 25 days ago
Director, Regulatory Affairs (US) Job Requisition ID: 32387 Department: REG Category: Corporate - M&A Location: Philadelphia Date: 9 Feb 2025 Come and Save Lives with Us!...
Regulatory Affairs Manager/Sr Manager (GCP)
- Princeton, NJ (17 miles from Newtown, PA)
- 29 days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 29 days ago
Theradex Systems, Inc. Theradex is an Equal Opportunity Employer. US-NJ-Princeton | US ID 2024-1336 Category Regulatory Type Full Time Who We Are Celebrating 40+ years! Theradex Oncology is a...
Senior Manager, Regulatory Affairs - Clinical Development
- Princeton, NJ (17 miles from Newtown, PA)
- 29 days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 29 days ago
We are seeking an experienced and highly motivated Senior Manager, Regulatory Affairs to support our expanding portfolio in the oncology area. This is an exciting opportunity to play a critical...
- Philadelphia, PA (24 miles from Newtown, PA)
- 30+ days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 30+ days ago
Director Regulatory Affairs Job ID: 7576 Job Title: Director Regulatory Affairs Location: Greater Philadelphia, PA Location: (Hybrid) Greater Philedelphia, PA (or) Boston, MA Position Our client is...
Senior Director, Regulatory Affairs, Combination Products
- Plymouth Meeting, PA (19 miles from Newtown, PA)
- 30+ days ago
- Plymouth Meeting, PA (19 miles from Newtown, PA)
- 30+ days ago
Job summary The Senior Director, Regulatory Affairs, Combination Products will have a broad span of responsibilities for leadership of regulatory strategy, regulatory submissions, and health authority...
Associate Manager - Regulatory Affairs - Labeling
- Plainsboro, NJ (20 miles from Newtown, PA)
- 45+ days ago
- Plainsboro, NJ (20 miles from Newtown, PA)
- 45+ days ago
and communicate effectively with relevant stakeholders to ensure timely resolution Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA...
Associate Director - Regulatory Affairs - Advertising & Promotion
- Plainsboro, NJ (20 miles from Newtown, PA)
- 45+ days ago
- Plainsboro, NJ (20 miles from Newtown, PA)
- 45+ days ago
Report to Senior Director, Regulatory Affairs - Advertising & Promotion....
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Princeton, NJ (17 miles from Newtown, PA)
- 60+ days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 60+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Demographic Data for Newtown, PA
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Salary for Director of Regulatory Affairs Jobs in Newtown, PA
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Director of Regulatory Affairss in Newtown, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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