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Regulatory Affairs Consultant - Labelling
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#661595
Full Time
Job Description
Canberra ACT
Full job description
Labelling specific expectations:
Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates
Use of document management tools (internal systems) and external platforms
Strong familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
Knowledge of the triggers that lead to a CCDS update, and ability to manage/coordinate impact assessments for technical changes impacting labelling
Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
Familiarity with CCDS governance processes in Pharma Companies
Some understanding of Periodic Safety Update Reports (PSUR) and potential impact on labelling
Appreciation of the relationship between labelling and artwork processes
Understanding of the regulatory processes required to update labelling of a product e.g different variation categories
Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labelling variation.
Some appreciation of the Regulatory requirements for labelling updates in different regions e.g. EU, EAEU, US and APAC.
Knowledge of local labelling requirements .
Review and approve promotion and advertising materials, medical education, and social media content in accordance with approved labelling and clinical materials. Participate in the promotion review committee and provide regulatory guidance in accordance with local market requirements.
Overarching project expectations:
Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)
Requirements:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
8 years + experience in an industry-related environment, inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility from Australia including New Zealand.
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
#LI-REMOTE
Full job description
Labelling specific expectations:
Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates
Use of document management tools (internal systems) and external platforms
Strong familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
Knowledge of the triggers that lead to a CCDS update, and ability to manage/coordinate impact assessments for technical changes impacting labelling
Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
Familiarity with CCDS governance processes in Pharma Companies
Some understanding of Periodic Safety Update Reports (PSUR) and potential impact on labelling
Appreciation of the relationship between labelling and artwork processes
Understanding of the regulatory processes required to update labelling of a product e.g different variation categories
Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labelling variation.
Some appreciation of the Regulatory requirements for labelling updates in different regions e.g. EU, EAEU, US and APAC.
Knowledge of local labelling requirements .
Review and approve promotion and advertising materials, medical education, and social media content in accordance with approved labelling and clinical materials. Participate in the promotion review committee and provide regulatory guidance in accordance with local market requirements.
Overarching project expectations:
Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)
Requirements:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
8 years + experience in an industry-related environment, inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility from Australia including New Zealand.
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
#LI-REMOTE
