Regulatory Affairs Managers plan, organise, direct, control, coordinate and promote adherence to regulatory frameworks and strategies within an organisation. They monitor regulatory environments and enable compliance.
Occupation description
Regulatory Affairs Managers plan, organise, direct, control, coordinate and promote adherence to regulatory frameworks and strategies within an organisation. They monitor regulatory environments and enable compliance.
Occupations considered suitable under this ANZSCO code:
- Regulatory Lead
- Regulatory Specialist
- Medical Affairs Advisor
- Regulatory Scientist
- Regulatory and Technical Affairs Associate
Occupations not considered suitable under this ANZSCO code:
Quality Assurance Manager
These occupations are classified elsewhere in ANZSCO or are not at the required skill level.
Regulatory Affairs Manager is a VETASSESS Group B occupation
This occupation requires a qualification assessed as comparable to the educational level of an Australian Qualifications Framework (AQF) Bachelor degree or higher.
Applicants must have fulfilled at least one of the following four criteria (1–4):
*Bachelor degree or higher degree includes:
- AQF master’s degree or
- AQF Doctoral Degree
** Additional qualifications in a highly relevant field of study include those comparable to the following levels:
- AQF Diploma
- AQF Advanced Diploma
- AQF Associate Degree or
- AQF Graduate Diploma
*** Highly relevant paid employment duration (20 hours or more per week)
Pathways 1-3
Minimum years of post-qualification employment highly relevant to the nominated occupation, completed at an appropriate skill level in the five years before the date of application for a Skills Assessment.
Pathway 4
Minimum 6 years of relevant employment required – Five years of relevant employment (can be outside the last 5-year period) in addition to at least one year of highly relevant employment within the last five years before applying.
Qualifications & employment criteria
Qualification
AQF Bachelor Degree or higher
This occupation requires a qualification in a field of high relevance to the occupational specialisation.
Bachelor degree and higher in a scientific or technical field. While there are no specific qualification in regulatory affairs, typical examples of highly relevant majors include (but are not limited to):
• Science
• Engineering
• Materials Science
• Agriculture
• Pharmaceutical Science
• Medical Science
Other fields may include:
• Policy and planning
• Project management and organisation
• Quality study/management
• Strategic Leadership/Operations
Employment
Highly relevant tasks include:
- developing regulatory strategies and implementing plans for new products
- provide high level strategic and technical advice on regulatory requirements
- liaise between R&D
- marketing, and senior management
- manage regulatory risks and ensure timely responses to regulatory queries
- manage regulatory affairs team
- staying abreast of changes in regulatory guidelines
Employment Information
Regulatory Affairs Managers oversee and manage regulatory processes to ensure the organisation’s products comply with all relevant regulatory standards.
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