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 Kao USA, Inc. 401(k) United States, York, York Jun 14, 2025 Oribe Hair Care has set the standard for professional hair care within the prestige market. Blending...
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
Director, US Regulatory Affairs Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing!...
Director, Regulatory Affairs and Quality, as well as with Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) regulatory teams....
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA
- 1 day ago
- Cambridge, MA
- 1 day ago
In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for the Regeneron Cell Medicines,...
Associate Director, Regulatory Affairs - Cardiac Rhythm Management
- Arden Hills, MN
- 1 day ago
- Arden Hills, MN
- 1 day ago
system activities and regulatory intelligence efforts Process Improvement & Collaboration Contribute to the development of best practices across the Regulatory Affairs function Support due diligence...
Director, Regulatory Affairs is expected to be a content specialist, with a keen understanding of overall nonclinical and clinical drug development, pharmacology, kinetics, immunology, and regulatory...
regulations, 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...
We are seeking an experienced and motivated Senior Director, Regulatory Affairs - CMC (Manufacturing)....
Regulatory Affairs Director - Global Regulatory Lead
- Washington, DC
- 2 days ago
- Washington, DC
- 2 days ago
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all...
Posting End Date:** **Work Place Flexibility:** Hybrid *****The preferred location for this position is Austin, TX. Qualified candidates within Entergys service territory may be considered in...
Senior Manager, Regulatory Affairs Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people...
Director of Regulatory Affairs MLTC (Juris Doctor Required) Hyrid
- New York, NY
- 3 days ago
- New York, NY
- 3 days ago
Director of Regulatory Affairs - MLTC (Hybrid) The Director of Regulatory Affairs is a senior leadership role responsible for the development, implementation, and oversight of regulatory compliance...
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
Senior Director of Regulatory Affairs at SecurityScorecard Remote (USA) About SecurityScorecard: SecurityScorecard is the global leader in cybersecurity ratings, with over 12 million companies continuously...
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
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Biotechnology
- Next-Generation Sequencing
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- GxP
- ISO 13485
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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