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.
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...
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...
HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and...
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
Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients....
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create...
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...
About the Role: We are seeking a Senior Manager, Regulatory Affairs to join our team....
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)....
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create...
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...
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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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
- 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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