Regulatory Affairs Professional Labelling (home or office based)
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams ensuring regulatory compliance and supporting product labelling management across multiple regions.
The role can be home or office based in various European locations.
Role Responsibilities:
Support Global Labelling Regulatory (Clinical/Safety) or Medical Writing teams for labelling updates
Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
Identify triggers for CCDS updates and coordinate impact assessments for technical changes
Apply knowledge of Safety Signal Management and its impact on labelling
Navigate CCDS governance processes in pharmaceutical environments
Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
Manage the relationship between labelling and artwork processes
Implement regulatory processes required to update product labelling (various variation categories)
Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
Apply regulatory requirements for labelling updates across different regions (EU EAEU US APAC)
Manage SmPC PIL and QRD requirements EU linguistic reviews and translation activities
Coordinate readability and PIL testing processes
Review and approve consumer-facing materials in accordance with approved labelling
Participate in promotion review committees and provide regulatory guidance for local markets
Provide technical and business consulting services within area of expertise
Complete activities within project scope timeline and objectives
Skills and Experience required for the role:
University Degree in a Scientific or Technical Discipline
Initial years of labelling/regulatory experience with global responsibilities
Regulatory Operations (Submission management) experience
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English written and spoken
Required Experience:
Unclear Seniority
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
