Hybrid programs blend both competency- and time-based strategies,
using a minimum and maximum range of hours for each major job
function and the successful demonstration of identified competencies.
using a minimum and maximum range of hours for each major job
function and the successful demonstration of identified competencies.
Regulatory Affairs Specialist
Rx Research Services
Documents
View Original Document
Individual state requirements may vary. Please contact your local apprenticeship office to ensure this version is suitable to your state’s requirements.
Work Process Content
On the Job Training
Anonymous
24
Skills
4K
OJT hours
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
1
190
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
1
190
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
1
180
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
1
180
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
1
180
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
1
180
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
1
180
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
1
180
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Ensure current regulations are communicated through corporate policies and procedures.
1
180
Ensure current regulations are communicated through corporate policies and procedures.
1
180
- Ensure current regulations are communicated through corporate policies and procedures.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
1
180
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
1
180
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
1
180
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
1
180
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
1
180
Prepare or maintain technical files as necessary to obtain and sustain product approval.
1
180
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
Coordinate efforts associated with the preparation of regulatory documents or submissions, and develop timelines for submissions.
1
180
Coordinate efforts associated with the preparation of regulatory documents or submissions, and develop timelines for submissions.
1
180
- Coordinate efforts associated with the preparation of regulatory documents or submissions, and develop timelines for submissions.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
1
180
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
1
180
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Analyze product complaints and make recommendations regarding their report ability.
1
180
Analyze product complaints and make recommendations regarding their report ability.
1
180
- Analyze product complaints and make recommendations regarding their report ability.
Participate in internal or external audits.
1
170
Participate in internal or external audits.
1
170
- Participate in internal or external audits.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
1
170
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
1
170
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
1
160
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
1
160
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
1
160
Review clinical protocols to ensure collection of data needed for regulatory submissions.
1
160
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
Compile and maintain regulatory documentation databases or systems.
1
160
Compile and maintain regulatory documentation databases or systems.
1
160
- Compile and maintain regulatory documentation databases or systems.
Recommend changes to company procedures in response to changes in regulations or standards.
1
160
Recommend changes to company procedures in response to changes in regulations or standards.
1
160
- Recommend changes to company procedures in response to changes in regulations or standards.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
1
150
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
1
150
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Write or update standard operating procedures, work instructions, or policies.
1
140
Write or update standard operating procedures, work instructions, or policies.
1
140
- Write or update standard operating procedures, work instructions, or policies.
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
1
140
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
1
140
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
1
130
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
1
130
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
1
170
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
1
170
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Coordinate recall or market withdrawal activities as necessary.
1
170
Coordinate recall or market withdrawal activities as necessary.
1
170
- Coordinate recall or market withdrawal activities as necessary.
Ensure collection and preparation of laboratory samples is conducted in accordance with GLP compliance.
1
130
Ensure collection and preparation of laboratory samples is conducted in accordance with GLP compliance.
1
130
- Ensure collection and preparation of laboratory samples is conducted in accordance with GLP compliance.
Related Instruction Content
Training Provider(s):
150
RI hours
OSHA General Industry
30
OSHA General Industry
30
OSHA HAZWOPER
20
OSHA HAZWOPER
20
Good Documentation Practices
10
Good Documentation Practices
10
Strategic Planning for Recalls
4
Strategic Planning for Recalls
4
Strategic Planning for Application
4
Strategic Planning for Application
4
Strategic Planning for Analysis
4
Strategic Planning for Analysis
4
Regulatory Framework
4
Regulatory Framework
4
Regulatory Pathways and Operations
4
Regulatory Pathways and Operations
4
Interaction with Other Companies
4
Interaction with Other Companies
4
Pre-Approval Non-Clinical Development (GLP/QSRs)
4
Pre-Approval Non-Clinical Development (GLP/QSRs)
4
Pre-Approval - Clinical Development (GCP)
4
Pre-Approval - Clinical Development (GCP)
4
Pre-Approval - CMC/Medical Device Design and Manufacturing (GMP, GXP overview)
4
Pre-Approval - CMC/Medical Device Design and Manufacturing (GMP, GXP overview)
4
Pre-Approval - FDA Agency Interaction
4
Pre-Approval - FDA Agency Interaction
4
Approval - Non-Clinical Development
4
Approval - Non-Clinical Development
4
Approval - Clinical Development
4
Approval - Clinical Development
4
Approval - CMC/Medical Device Design and Manufacturing
4
Approval - CMC/Medical Device Design and Manufacturing
4
Regulatory Submission and Review Process
4
Regulatory Submission and Review Process
4
Post marketing/Regulatory Maintenance
4
Post marketing/Regulatory Maintenance
4
Post marketing Surveillance/Vigilance
4
Post marketing Surveillance/Vigilance
4
Advertising/Promotion/Labeling
4
Advertising/Promotion/Labeling
4
Distribution
4
Distribution
4
Crisis Management
4
Crisis Management
4
Agency Interaction
4
Agency Interaction
4
Regulatory Affairs Certificate Exam
4
Regulatory Affairs Certificate Exam
4
Foreign Language
4
Foreign Language
4