Senior Regulatory Affairs Associate Labelling (home or office based)
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Job Location:
Monthly Salary:
Posted on:
21 hours 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 an experienced Senior Regulatory Affairs Associate Labelling to develop and execute artwork strategies for our global product this critical role you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.
The role can be home or office based in various European locations.
Role Responsibilities:
- Prepare Label updates for EU US and ROW markets
- Coordinate readability testing
- Coordinate and manage translations for EU markets
- Management of linguistic review
- Manage GRA label Compliances (e.g. QC process)
- Develop manage and track label governance for EU US and ROW markets
- Prepare & support Label negotiations for EU US and ROW markets
- Manage/coordinate global labeling change impact assessment for dependent markets
- Manage and track governance for label content creation for EU US and ROW markets
- Develop manage and trackgovernance for company position (e.g. CCDS) and foundational markets
- Manage advertising and promotion materials
- Prepare and management artwork
- Labeling summaries for periodic reports
Skills and Experience required for the role:
Bachelors Degree in a Scientific or Technical Discipline
In-depth understanding of pharmaceutical industry regulations particularly in Regulatory Affairs
Capable of reviewing technical documents and influencing colleagues across functions.
Strong knowledge of US EU DE CH AU regulatory labeling lifecycle management.
Experience in Flu campaigns and pandemic products.
Strong project management capabilities
Client-focused approach with results orientation
Excellent teamwork and collaboration abilities
Critical thinking and problem-solving aptitude
Fluent in English written and spoken
Required Experience:
Senior IC
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
