Manager of Regulatory Affairs Jobs in Collegeville, PA
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.
- Philadelphia, PA (21 miles from Collegeville, PA)
- 16 days ago
- Philadelphia, PA (21 miles from Collegeville, PA)
- 16 days ago
The Manager of Regulatory Affairs executes the readiness processes to ensure compliance with regulations and standards of regulatory and accreditation agencies....
Director of Regulatory Affairs
- Malvern, PA (11 miles from Collegeville, PA)
- 18 days ago
- Malvern, PA (11 miles from Collegeville, PA)
- 18 days ago
Job Purpose The Director of Regulatory Affairs will lead regulatory strategy, submission planning, and execution for Ocugens biologics, cell, and gene therapy programs. This role is responsible...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA
- 29 days ago
- Collegeville, PA
- 29 days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Mar 20 2025 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global...
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Salary for Manager of Regulatory Affairs Jobs in Collegeville, PA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Collegeville, PA 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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