Regulatory submissions skills matrix template
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With our free regulatory submissions skills matrix template, you will receive a clear overview of the skills that are present in your organization, as well as those that are missing. Using this information, you can develop and implement a plan to ensure that your employees’ skills are up to date, comprehensive, compliant, and ready for the future.
- Certified Regulatory Affairs Professional (CRAP)
- Certified Regulatory Specialist (CRS)
- Certified Regulatory Compliance Professional (CRCP)
- Certified Regulatory Affairs Manager (CRAM)
- Certified Regulatory Affairs Consultant (CRAC)
- Certified Medical Device Regulatory Affairs Professional (CMDRAP)
- Certified Pharmaceutical Regulatory Affairs Professional (CPRAP)
- Certified Biotechnology Regulatory Affairs Professional (CBRAP)
- Certified Food Regulatory Affairs Professional (CFRAP)
- Certified Cosmetics Regulatory Affairs Professional (CCRAP)
- Certified Veterinary Regulatory Affairs Professional (CVRAP)
- Certified Chemical Regulatory Affairs Professional (CCRAP)
- Certified Environmental Regulatory Affairs Professional (CERAP)
- Certified Health Product Regulatory Affairs Professional (CHPRAP)
- Certified Nutraceutical Regulatory Affairs Professional (CNRAP)
- Certified Hazardous Materials Regulatory Affairs Professional (CHMRAP)
- Certified Medical Writing Professional (CMWP)
- Certified Regulatory Compliance Manager (CRCM)
- Certified Quality Assurance Professional (CQAP)
- Certified Compliance and Regulatory Affairs Auditor (CCRAA)
Regulatory Knowledge: Proficiency in understanding regulatory requirements, guidelines, and standards is crucial for preparing accurate and compliant regulatory submissions. While there are no specific certifications solely focused on regulatory submissions, certifications such as the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) demonstrate expertise in regulatory affairs and compliance management.
Document Preparation and Management: Skills in preparing and managing regulatory documents, including writing, formatting, and version control, are important for efficient and organized submissions. Certifications such as the Certified Document Control Professional (CDCP) offered by the Association for Information and Image Management (AIIM) validate expertise in document control practices.
Quality Management Systems (QMS): Familiarity with QMS principles and practices, including documentation requirements, is valuable in regulatory submissions. Certifications such as the Certified Manager of Quality/Organizational Excellence (CMQ/OE) from the American Society for Quality (ASQ) encompass topics related to QMS and regulatory compliance.
Submission Planning and Strategy: Proficiency in developing submission plans and strategies, including timelines, deliverables, and communication plans, is essential for successful regulatory submissions. While there are no specific certifications solely focused on submission planning, project management certifications such as the Project Management Professional (PMP) from the Project Management Institute (PMI) demonstrate competence in project planning and management.
Regulatory Intelligence and Compliance: Staying updated with regulatory changes, industry trends, and compliance requirements is crucial in regulatory submissions. Certifications such as the Certified Compliance and Ethics Professional (CCEP) offered by the Society of Corporate Compliance and Ethics (SCCE) demonstrate expertise in compliance management practices.
Skills management software is important in regulatory submissions to track and manage the skills of individuals involved in preparing and managing regulatory documents. It ensures that professionals possess skills in regulatory knowledge, document preparation, quality management systems, and compliance to ensure accurate and compliant regulatory submissions.