Manager of Regulatory Affairs Jobs in Pennsylvania
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
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...
Commercial Regulatory Affairs Director
- King of Prussia, PA
- 12 days ago
- King of Prussia, PA
- 12 days ago
**ESSENTIAL DUTIES AND RESPONSIBILITIES:** Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA
- 14 days ago
- Collegeville, PA
- 14 days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2025 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Job Description Position Overview The Manager, Regulatory Affairs will represent Invenergy within the PJM stakeholder processes, state economic regulatory bodies within the PJM footprint, and related...
Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: evaluate Change Requests/Change Controls and provide accurate regulatory assessments for changes...
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...
Associate Director, Regulatory Affairs City : Malvern State : PA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking an Associate Director, Regulatory Affairs in...
Want to help us bring happiness to the world? Want to join an ambitious and fast growing global biscuits and confectionery business investing heavily in iconic global brands, infrastructure and...
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Salary for Manager of Regulatory Affairs Jobs in Pennsylvania
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Pennsylvania offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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