Director of Regulatory Affairs Jobs in King Of Prussia, 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.
Associate Director, Regulatory Affairs (mRNA vaccines)
- Collegeville, PA (6 miles from King Of Prussia, PA)
- 7 days ago
- Collegeville, PA (6 miles from King Of Prussia, PA)
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Director of Regulatory Affairs, Academic Affairs Office, Penn Law
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 9 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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...
Director, Regulatory Affairs, Specialty
- Collegeville, PA (6 miles from King Of Prussia, PA)
- 9 days ago
- Collegeville, PA (6 miles from King Of Prussia, PA)
- 9 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Associate Director Regulatory Affairs (Immune Health Institute) University of Pennsylvania
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 14 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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 (15 miles from King Of Prussia, PA)
- 14 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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...
Regulatory Affairs Manager, North America (Bilingual)
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 20 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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 (15 miles from King Of Prussia, PA)
- 21 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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, Regulatory Affairs (US)
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 25 days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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!...
- Philadelphia, PA (15 miles from King Of Prussia, PA)
- 30+ days ago
- Philadelphia, PA (15 miles from King Of Prussia, 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 (6 miles from King Of Prussia, PA)
- 30+ days ago
- Plymouth Meeting, PA (6 miles from King Of Prussia, 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...
Demographic Data for King Of Prussia, PA
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Salary for Director of Regulatory Affairs Jobs in King Of Prussia, PA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in King Of Prussia, 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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