Director of Regulatory Affairs Jobs in Topeka, KS
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.
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Demographic Data for Topeka, KS
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Salary for Director of Regulatory Affairs Jobs in Topeka, KS
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Topeka, KS offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- TrackWise
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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