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 Regulatory Affairs Manager, Advertising and
- Deerfield, IL
- 14 hours ago
- Deerfield, IL
- 14 hours 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
- 4 days ago
- Lake Zurich, IL
- 4 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
- 6 days ago
- Deerfield, IL
- 6 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
- 12 days ago
- North Chicago, IL
- 12 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
- 18 days ago
- Mettawa, IL
- 18 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...
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...
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 WorkJob Summary This role maintains clinical trial regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits....
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 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
- 30+ days ago
- Chicago, 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...
Manager, Regulatory Affairs (Ophthalmic Laser)
- Springfield, IL
- 30+ days ago
- Springfield, IL
- 30+ days ago
Manager, Regulatory Affairs (Ophthalmic Laser) Company: Bausch + Lomb Location: Springfield, IL Date Posted: 2/25/25, 4:27 AM Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company...
Our client, a full range supplier of automotive coatings market is seeking a Regulatory Affairs Manager to join their team. As a Regulatory Affairs Manager, you will be part of the management team...
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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
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- 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
- Implementation
- Military Background
- 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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