Director of Regulatory Affairs Jobs in Oak Brook, 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 Strategy
- Chicago, IL (15 miles from Oak Brook, IL)
- 6 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 6 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for contributing...
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...
Manager/Senior Manager, Regulatory Affairs - CDx
- Chicago, IL (15 miles from Oak Brook, IL)
- 17 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 17 days ago
CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of...
Remote Work- Chicago, IL (15 miles from Oak Brook, IL)
- 19 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 19 days ago
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....
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL (15 miles from Oak Brook, IL)
- 20 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 20 days ago
Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with...
Regulatory Affairs Manager - JR29338-3800
- Chicago, IL (15 miles from Oak Brook, IL)
- 20 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 20 days ago
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....
Regulatory Affairs Manager (Greater Chicago Area, IL)
- Chicago, IL (15 miles from Oak Brook, IL)
- 23 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 23 days ago
The Regulatory Affairs Manager reports to and assists the Director of Regulatory Affairs and Product Engineering....
- Chicago, IL (15 miles from Oak Brook, IL)
- 24 days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 24 days ago
Regulatory Affairs Manager II#25-53978 Chicago, IL Fully Remote Job Description 100% Remote (EST time zone) 12 months *** per hour max bill rate Performs eCTD submission management across ***'s...
Remote WorkManager, Regulatory Affairs - Advertising & Promotion
- Chicago, IL (15 miles from Oak Brook, IL)
- 30+ days ago
- Chicago, IL (15 miles from Oak Brook, IL)
- 30+ days ago
Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and...
Demographic Data for Oak Brook, IL
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Salary for Director of Regulatory Affairs Jobs in Oak Brook, IL
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Oak Brook, 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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