Regulatory Affairs Consultant Labelling
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Job Location:
Monthly Salary:
Posted on:
6 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 experiencedRegulatory Affairs Consultantspecializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.
The role can be fully home based or office based.
Key Responsibilities:
Manageend-to-end labeling lifecycleincluding preliminary assessment implementation and post-approval maintenance
Provide innovation and technical expertise for the creation maintenance and implementation of labeling to meetcountry-specific regulatory requirements
Execute labeling operations globally with precision and efficiency
Participate in afollow the sun modelto ensure timely execution of labelling activities across time zones
Prepare and review labelling documents for regulatory submissions and variations
Maintain labeling databases and tracking systems
Support global labelling harmonization initiatives
Collaborate with regional regulatory teams to ensure compliance with local requirements
Monitor regulatory intelligence related to labelling requirements
Skills and Experienced required for the role:
University degree in a life science discipline
A few yearsof experience in the biotech/pharmaceutical industry
Labelling/regulatory experiencewith global responsibilities
Experience with CCDS development and maintenance
Strong understanding of regulatory labelling requirements across multiple markets
Direct experience working with Swissmedic
Excellent attention to detail and organizational skills
Experience leading teams in amatrix organizationis expected
Ability to work effectively in a global virtual team environment
Fluent in German and English written and spoken
Required Experience:
Contract
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
