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.
Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About...
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 2 hours ago
- Santa Clara, CA
- 2 hours 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...
Senior Regulatory Affairs Manager, Advertising and
- Deerfield, IL
- 11 hours ago
- Deerfield, IL
- 11 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...
Job Listing ID: 4259842 Job Title: Senior Manager, Regulatory Affairs Application Deadline: Open Until FilledJob Location: Salem Date Posted: 04/25/2025Hours Worked Per Week: Not Provided Shift:...
Director Regulatory Affairs CMC I am looking to speak with Director's of Regulatory Affairs CMC to lead the development and execution of global CMC regulatory strategies for clinical-stage small molecule...
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA
- 1 day ago
- Pleasanton, CA
- 1 day 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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA
- 2 days ago
- Cambridge, MA
- 2 days ago
The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir....
Remote WorkBausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA
- 2 days ago
- Santa Clara, CA
- 2 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and Responsibilities...
Regulatory Affairs Manager (RoW), Temporary Position - Reykjavik (Iceland)
- VA
- 2 days ago
- VA
- 2 days ago
Regulatory Affairs Manager (RoW), Temporary Position Reykjavik (Iceland) - Full time Deadline: May 4, 2025 Alvotech is seeking a proactive and detail-oriented Regulatory Affairs Manager for the...
Systems, and import/export requirements Experience as the RA representative on project core teams Strong communication and teamwork skills Ability to lead multiple projects and meet deadlines Capacity...
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory hire...
Manager/Senior Manager, Regulatory Affairs CMC
- South San Francisco, CA
- 3 days ago
- South San Francisco, CA
- 3 days ago
What you'll do: Develop and implement CMC regulatory strategies for investigational and marketed products to ensure successful regulatory submissions and approvals. Author or review CMC sections...
We are building a next-generation precision medicine company focused on immunology and inflammation.The company's Mirador360 precision development engine leverages the latest advances in human...
Business Operations Manager: Regulatory Affairs 4.1 4.1 out of 5 stars Research Triangle Park, NC The application window is expected to close on: 4.29.2025 Job posting may be removed earlier if...
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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
- 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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