Director of Regulatory Affairs Jobs
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.
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA
- 30+ days ago
- Alameda, CA
- 30+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
This position reports to the Director, Regulatory Affairs, Operations and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
Summary of Position The Director of Regulatory Affairs is responsible for Regulatory Affairs dossiers and associated regulatory affairs compliance and operations activities in the US....
Manager, Regulatory Affairs (Advertising and Promo
- Deerfield, IL
- 3 hours ago
- Deerfield, IL
- 3 hours ago
at Vantive US Healthcare LLC in Deerfield, Illinois, United States Job Description Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and...
Manager Regulatory Affairs-Front Line Care (FLC)
- Skan Falls, NY
- 4 hours ago
- Skan Falls, NY
- 4 hours 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. You'll feel...
FDA regulations, ICH guidelines)....
Regulatory Affairs Manager** The Regulatory Affairs Manager will be responsible for managing the bank's interactions with regulatory agencies and ensuring that the bank adheres to regulatory...
Senior Manager Regulatory Affairs, Advertising and Promotion - Job ID: 1690
- Princeton, NJ
- 1 day ago
- Princeton, NJ
- 1 day ago
As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs, Advertising and Promotion....
Job Summary The Director, Regulatory Affairs is a senior leadership role responsible for overseeing all aspects of regulatory compliance, advocacy, and strategic engagement with regulatory bodies....
As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the power of chemistry to shape markets, redefine industries and improve lives for...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
Piper Companies is currently looking for an experienced Associate Director of Regulatory Affairs in Eden Prairie, Minnesota (MN) to work for an innovative and growing pharmaceutical manufacturer....
Regulatory Affairs Manager (Disney Vacation Club)
- Celebration, FL
- 2 days ago
- Celebration, FL
- 2 days ago
Disney Vacation Club (DVC) is a highly complex and regulated business. DVC continues to experience material growth and added complexity within the product structure and policies & procedures. The...
Associate Director, Regulatory Affairs, Specimen Management
- Franklin Lakes, NJ
- 2 days ago
- Franklin Lakes, NJ
- 2 days ago
Summary The Associate Director, Regulatory Affairs, Specimen Management (SM) reports directly to the Vice President, Regulatory Affairs, Specimen Management....
Director of Regulatory Affairs Online Courses and Training Opportunities
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss 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
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- ICH GCP
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Microbiology
- Medical Device Sales
- Document Management
- Product Launch
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Military Background
- Written Communication
- Mentoring
- Interpersonal Skills
- Employee Development
- Collaboration
- Documentation
- Reporting
- Coaching
- Filing
- Regulations
- Policy Development
- Bachelor's Degree
- Microsoft PowerPoint
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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