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.
The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or...
Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of...
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
BS Degree in Regulatory Science, Food Science/Technology, Nutrition, or related scientific field 4-6 years of relevant regulatory experience in the food/supplement industry Strong understanding of FDA...
The Opportunity This position, Associate Director Regulatory Affairs, works out of our San Diego, CA location in the Infectious Diseases Division....
This Manager will report to the Senior Director Regulatory Affairs and will work remotely with as needed work out of our campus in Thousand Oaks, CA....
Remote WorkRegulatory Affairs Director - Global Regulatory Lead
- Washington, DC
- 1 day ago
- Washington, DC
- 1 day 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...
Senior Manager, Regulatory Affairs CMC (Onsite Hybrid)
- North Chicago, IL
- 1 day ago
- North Chicago, IL
- 1 day ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable...
Director, Regulatory Affairs- This position can be based either in our San Diego, CA or Minnetonka, MN location. Welcome to an inspired career....
Regulatory Affairs Manager or Senior Manager*REQUISITION:*STA0004*DEPARTMENT:*Regulatory Affairs - Kansas City Headquarters or Topeka General Office*LOCATION: *Kansas City, MO or Topeka, KS *PAY...
This position reports to the Director, Regulatory Affairs and will be ideally located in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
- Weston, FL
- 2 days ago
- Weston, FL
- 2 days ago
We are currently seeking a **Senior Manager, Regulatory Affairs** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). This is a hybrid position based in Mahwah,...
Director, Regulatory Affairs- This position can be based either in our San Diego, CA or Minnetonka, MN location. Welcome to an inspired career....
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented...
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.
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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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Systems
- Quality Management 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
- Strategic Planning
- Verbal Communication
- 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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