Regulatory Affairs Consultant – Labelling
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇦🇺 Australia
Visit company websiteJob Level
SeniorLead
About the role
- 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.
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
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
labeling updatesregulatory experiencedocument management toolsCCDS implementationSafety Signal ManagementPeriodic Safety Update Reportsregulatory processesAddendum to Clinical Overviewlocal labeling requirements
Soft skills
client-focused approachresults orientationteamworkcollaboration skillsconsulting skillsinterpersonal communicationintercultural communicationcritical thinkingproblem-solving
Certifications
Bachelor’s DegreeAdvanced Degree