Director of Regulatory Affairs Jobs in Illinois
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.
Senior Manager Regulatory Affairs, CMC and Regulatory Sciences
- Chicago, IL
- 8 days ago
- Chicago, IL
- 8 days ago
Description Senior Manager Regulatory Affairs - CMC CMC, and Regulatory Sciences About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of...
Job Standards Department: Office of Public Utilities Division: Regulatory Affairs Final Date to Apply: 8/21/2025 at 11:00 PM CST, Open to All Applicants Work Location: 800 East Monroe St....
Director Regulatory Affairs Alliance and Commercialization
- Deerfield, IL
- 9 days ago
- Deerfield, IL
- 9 days 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 (Advertising and Promo
- Deerfield, IL
- 16 days ago
- Deerfield, IL
- 16 days ago
at Vantive US Healthcare LLC in Deerfield, Illinois, United States Job Description Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and...
Program Manager, Regulatory Affairs, Anesthesia & Respiratory Care
- Chicago, IL
- 30+ days ago
- Chicago, IL
- 30+ days ago
Summary** Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market...
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...
The Opportunity Our location in Lake Forest, IL currently has an opportunity for the Director of Regulatory Affairs....
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Salary for Director of Regulatory Affairs Jobs in Illinois
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Illinois 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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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