Director of Regulatory Affairs Jobs in Saint Louis, MO
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.
(Contractor) Senior Manager Regulatory Affairs
- Saint Louis, MO
- 9 days ago
- Saint Louis, MO
- 9 days ago
Contractor) Senior Manager Regulatory Affairs Curium Pharma United States, Missouri, St. Louis 111 West Port Plaza Drive (Show on map) Jun 03, 2025 (Contractor) Senior Manager Regulatory Affairs...
Seeking a Senior Manager Regulatory Affairs for contract position focused on new chemical entity submissions and existing product management. Requirements: BS Degree in Chemistry, Pharmacy,...
Salary Range: $109,600.00 - $164,400.00 Purpose Statement: The Global Regulatory Affairs Manager leads the execution of the Quality Management System (QMS) processes in order to ensure compliance with...
- Saint Charles, MO (20 miles from Saint Louis, MO)
- 24 days ago
- Saint Charles, MO (20 miles from Saint Louis, MO)
- 24 days ago
Job Level: Technical Leadership-T2 Job Description: Being part of the Royal Canin Regulatory Affairs department, specifically within the Global Market Access Strategy team, this role is essential...
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Salary for Director of Regulatory Affairs Jobs in Saint Louis, MO
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Saint Louis, MO 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
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- 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
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- 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
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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