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.
Title : Regulatory Affairs Manager Term : 6 month renewable contract Location : 100% Remote Pay : $60$65/hour Required experience : Minimum of 7 years of experience in Regulatory Affairs...
Remote WorkUSA - 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...
Associate Director, Regulatory Affairs Advertising & Promotion - Immunology
- Mettawa, IL
- 20 hours ago
- Mettawa, IL
- 20 hours ago
Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...
Manager, Regulatory Affairs CMC (Onsite Hybrid)
- North Chicago, IL
- 7 days ago
- North Chicago, IL
- 7 days ago
Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management....
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at Silliker, Inc in Chicago, Illinois, United States Job Description Regulatory Affairs Manager - Pet Food Remote Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is...
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Dermatology
- Mettawa, IL
- 8 days ago
- Mettawa, IL
- 8 days ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable...
Minimum qualifications: Bachelor's degree in Business, Accounting, Finance, or equivalent practical experience. 4 years of experience in management consulting, or project management from a public...
Senior Regulatory Affairs Manager, Advertising and
- Deerfield, IL
- 10 days ago
- Deerfield, IL
- 10 days ago
at Baxter Healthcare Corporation in Deerfield, Illinois, United States Job Description This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your...
Director, Regulatory Affairs (Global Biosimilar)
- Lake Zurich, IL
- 14 days ago
- Lake Zurich, IL
- 14 days ago
at Fresenius Kabi USA, LLC in Lake Zurich, Illinois, United States Job Description Job Summary The Director, Regulatory Affairs is responsible to develop and execute regulatory strategy for biosimilar...
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...
Senior Regulatory Affairs Manager, Advertising and Promotion
- Deerfield, IL
- 16 days ago
- Deerfield, IL
- 16 days ago
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel...
Senior Manager, Regulatory Affairs CMC (Onsite Hybrid)
- North Chicago, IL
- 22 days ago
- North Chicago, IL
- 22 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Department: 10199 Advocate Aurora Health Corporate - Government Affairs Status: Full time Benefits Eligible: Yes Hou rs Per Week: 40 Schedule Details/Additional Information: The position is F/T,...
Remote WorkMajor Responsibilities: Accountability for large, complex proposed rule comment filings, with an understanding that the quality of work product strongly impacts the Federal Affairs and Government...
Job Summary This role maintains clinical trial regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits....
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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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- 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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