Director of Regulatory Affairs Jobs in Pennsylvania
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.
The Senior Director of Regulatory Affairs will define and implement innovative regulatory strategies that expedite the development and approval of our portfolio of investigational products....
Associate Director, Regulatory Affairs - Labeling Management
- North Wales, PA
- 5 days ago
- North Wales, PA
- 5 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Reporting to the Executive Director, Regulatory Affairs - CMC, the Associate Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory...
We're looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline....
We're looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline....
Director, Regulatory Affairs - Specialty Medicine
- Collegeville, PA
- 15 days ago
- Collegeville, PA
- 15 days ago
Were looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline....
**Job Summary** The Director, Regulatory Affairs is a senior leadership role responsible for overseeing all aspects of regulatory compliance, advocacy, and strategic engagement with regulatory bodies...
Who We Are At Freshpet, our goal is to change the way people nourish their pets forever. We strive to strengthen the bond between people and our pets so that we both live longer, healthier, and...
Director, Regulatory Affairs - Dossier Project Manager
- West Chester, PA
- 30+ days ago
- West Chester, PA
- 30+ days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
Regulatory Affairs Manager Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in Philadelphia, PA. We are a...
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Salary for Director of Regulatory Affairs Jobs in Pennsylvania
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Pennsylvania 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
- Biochemistry
- Biology
- Immunology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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