Manager of Regulatory Affairs Jobs in Illinois
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Senior Manager, Regulatory Affairs CMC (Onsite Hybrid)
- North Chicago, IL
- 2 days ago
- North Chicago, IL
- 2 days ago
Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients....
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...
Manager, Regulatory Affairs US Advertising and Promotion - Immunology
- Mettawa, IL
- 8 days ago
- Mettawa, IL
- 8 days ago
Job Description The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed...
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....
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL
- 19 days ago
- Chicago, IL
- 19 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...
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
- 22 days ago
- Chicago, IL
- 22 days ago
The Regulatory Affairs Manager reports to and assists the Director of Regulatory Affairs and Product Engineering. This Position Supports and assists the Director in formulating Regulatory...
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 configuration...
Manager, Regulatory Affairs (Ophthalmic Laser)
- Springfield, IL
- 27 days ago
- Springfield, IL
- 27 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 dedicated...
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...
system....
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Illinois offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- 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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