Director of Regulatory Affairs Jobs in Chicago, IL
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.
Director Regulatory Affairs Alliance and Commercialization - Remote Opportunity
- Deerfield, IL (21 miles from Chicago, IL)
- 20 hours ago
- Deerfield, IL (21 miles from Chicago, IL)
- 20 hours ago
Remote opportunitiy - Open to candidates anywhere in the greater United States SUMMARY: The Director, US Regulatory Affairs Alliance and Commercialization, will oversee and lead regulatory affairs strategy...
Manager, Regulatory Affairs Pharmacovigilance
- Markham, IL (20 miles from Chicago, IL)
- 1 day ago
- Markham, IL (20 miles from Chicago, IL)
- 1 day ago
Manager, Regulatory Affairs Pharmacovigilance Markham, ON At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare...
Minimum qualifications: Bachelor's degree in Business, Accounting, Finance, or equivalent practical experience. 2 years of experience in management consulting or project management from a public...
at Invenergy LLC in Chicago, Illinois, United States Job Description Invenergy drives innovation in energy. Powered by decades of entrepreneurial experience and unparalleled execution, we solve...
Invenergy drives innovation in energy. Powered by decades of entrepreneurial experience and unparalleled execution, we solve the energy challenges facing our customers and communities. We provide...
at GE HealthCare in Chicago, Illinois, United States Job Description Job Description Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs - CMC professional with a...
USA - Regulatory Affairs Manager
- Deerfield, IL (21 miles from Chicago, IL)
- 30+ days ago
- Deerfield, IL (21 miles from Chicago, IL)
- 30+ days ago
USA - Regulatory Affairs Manager#25-57898 $56.09-$59.09 per hour Deerfield, IL All On-site Job Description Senior Regulatory Affairs Manager, Advertising and Promotion Location: Deerfield Open to...
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
- Lincolnshire, IL (23 miles from Chicago, IL)
- 90+ days ago
system....
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Salary for Director of Regulatory Affairs Jobs in Chicago, IL
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Chicago, IL 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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