Director of Regulatory Affairs Jobs in Deerfield, 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.
Program Manager, Regulatory Affairs Finance
- Chicago, IL (21 miles from Deerfield, IL)
- 2 hours ago
- Chicago, IL (21 miles from Deerfield, IL)
- 2 hours ago
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...
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 (8 miles from Deerfield, IL)
- 5 days ago
- Lake Zurich, IL (8 miles from Deerfield, IL)
- 5 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...
Senior Regulatory Affairs Manager, Advertising and Promotion
- Deerfield, IL
- 7 days ago
- Deerfield, IL
- 7 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 (10 miles from Deerfield, IL)
- 13 days ago
- North Chicago, IL (10 miles from Deerfield, IL)
- 13 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...
Manager, Regulatory Affairs US Advertising and Promotion - Immunology
- Mettawa, IL (4 miles from Deerfield, IL)
- 19 days ago
- Mettawa, IL (4 miles from Deerfield, IL)
- 19 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...
Manager/Senior Manager, Regulatory Affairs - CDx
- Chicago, IL (21 miles from Deerfield, IL)
- 27 days ago
- Chicago, IL (21 miles from Deerfield, IL)
- 27 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 (21 miles from Deerfield, IL)
- 29 days ago
- Chicago, IL (21 miles from Deerfield, IL)
- 29 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 - JR29338-3800
- Chicago, IL (21 miles from Deerfield, IL)
- 30+ days ago
- Chicago, IL (21 miles from Deerfield, IL)
- 30+ 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....
- Chicago, IL (21 miles from Deerfield, IL)
- 30+ days ago
- Chicago, IL (21 miles from Deerfield, IL)
- 30+ 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 (21 miles from Deerfield, IL)
- 30+ days ago
- Chicago, IL (21 miles from Deerfield, 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...
- Lincolnshire, IL (2 miles from Deerfield, IL)
- 90+ days ago
- Lincolnshire, IL (2 miles from Deerfield, IL)
- 90+ days ago
system....
Demographic Data for Deerfield, IL
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Salary for Director of Regulatory Affairs Jobs in Deerfield, IL
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Deerfield, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- 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
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- 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
- Scheduling
- Leadership
- Communication Skills
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