Manager of Regulatory Affairs Jobs
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.
Regulatory Affairs Manager Adverising and Promo
- Bridgewater, NJ
- 2 hours ago
- Bridgewater, NJ
- 2 hours ago
Regulatory Specialist Ad Promo (Pharma/Consumer Health) Location: Remote Contract Length: 6 months Pay Rate: $70$100/hour Schedule: MondayFriday, 8am5pm ET (preferred) We are seeking a Regulatory...
Senior Manager, Regulatory Affairs - Device (Hybrid Onsite)
- North Chicago, IL
- 4 hours ago
- North Chicago, IL
- 4 hours ago
Job Description The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients....
Senior Director Regulatory Affairs, Advertising & Promotion
- Houston, TX
- 7 hours ago
- Houston, TX
- 7 hours ago
This role chairs the PRC, manages OPDP/APLB interactions, supports labelling negotiations, and ensures promotional content complies with FDA regulations....
Associate Director, Regulatory Affairs
- Franklin Lakes, NJ
- 7 hours ago
- Franklin Lakes, NJ
- 7 hours ago
Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations....
Clinical Research Regulatory Affairs Manager
- South San Francisco, CA
- 20 hours ago
- South San Francisco, CA
- 20 hours ago
Manager, Regulatory Affairs At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the...
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
Manager, Regulatory Affairs Supervisor/Manager Title: Director, Regulatory Affairs Job Description Summary: Responsible for timely preparation and submission of organized, scientifically valid global...
at GE HealthCare in Chicago, Illinois, United States Job Description Job Description Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs - CMC professional with a...
Remote Workregulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA
- 4 days ago
- Foster City, CA
- 4 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
in Regulatory Affairs Demonstrate knowledge of regulation and cost of service issues Understand industry tariffs and rate design MINIMUM POSITION QUALIFICATIONS Bachelors degree from an accredited...
The Director, Regulatory Affairs has the responsibility for activities pertaining to regulatory strategy and submissions to the FDA and other Health Authorities, writting annual reports, and...
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned...
Regulatory Affairs Manager Location: Hybrid remote with 2-3 per week in office, must reside in a service area state commutable to Dover, DE; West Palm, FL; or Yulee, FL office locations What makes...
NOW HIRING: Regulatory Affairs Director On-Site | Chemical & Product Manufacturing | Leadership Role | Global Compliance Are you a regulatory power house with a sharp eye for detail and a passion...
Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs Nationwide
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss 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
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- ICH Guidelines
- 21 CFR 820
- ISO 13485
- Change Control
- GxP
- Good Laboratory Practice
- Good Manufacturing Practices
- Microbiology
- Medical Device Sales
- Document Management
- Product Launch
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Diagnostic
- Product Development
- Engineering
- Strategy Development
- Auditing
- Implementation
- Military Background
- Quality Assurance
- Written Communication
- Documentation
- Mentoring
- Coaching
- Education Experience
- Verbal Communication
- Reporting
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Policy Development
- Filing
- Project Management
- Regulations
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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