Regulatory Compliance Specialist III (Engineering)
We Care Staffing
Job Description
Knowledge, Skills & Competencies:
• Strong authoring skills of documentation and Health Authority responses
• Ability to resolve strategic technical and regulatory issues
• Should demonstrate initiative, analytical thinking and works independently
• Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders
• Experience working with a Health Authority is helpful but not essential
• Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful
Qualifications:
Education / Experience
• Bachelor's degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Master's degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing
• Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines
• Ability to manage multiple priorities efficiently
• Experience working on Project teams
• Demonstrated knowledge of microbiology, immunology, virology or bacteriology
• Excellent skills in communication, writing and teamwork
Knowledge, Skills & Competencies:
• Strong authoring skills of documentation and Health Authority responses
• Ability to resolve strategic technical and regulatory issues
• Should demonstrate initiative, analytical thinking and works independently
• Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders
• Experience working with a Health Authority is helpful but not essential
• Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful
Qualifications:
Education / Experience
• Bachelor's degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Master's degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing
• Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines
• Ability to manage multiple priorities efficiently
• Experience working on Project teams
• Demonstrated knowledge of microbiology, immunology, virology or bacteriology
• Excellent skills in communication, writing and teamwork
Vacancy posted 4 days ago
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