Manager Labelling And Regulatory Submissions - (X875)
Responder al anuncioWe are growing, grow with us! Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.
The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us!
To strengthen our successful team, we are looking for a:
Manager Labelling and Regulatory Submissions
Your Job:
- Participation in the preparation, revision, and compilation of informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles.
- Manage creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e. g. from medical, safety department).
- Ensure communication to internal/external stakeholders regarding new and updated CCDSs.
- Escalate deviation and compliance issues to the labelling governance bodies (e. g. Safety monitoring committee, Global labelling boards) as necessary.
- Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level.
- Ensure that regulatory affairs, development consulting and scientific affairs programs and projects are delivered to high standards.
- Plan and expedite the approval projects using the internally available or client-based software tools including databases and document management systems.
- Provide regulatory expertise to regulatory programs and projects as well as to clients.
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including updates on new trends and/or changes in legislation.
- Present seminars and lectures on behalf of PharmaLex internally, for customers and for professional audiences.
- Create, revise, edit, and maintain regulatory documentation.
- Professional interaction with clients and Health Authorities.
- Coordination of project teams with internal/external staff and Regulatory Alliance Partners on a worldwide level.
- Participation in strategic regulatory issues.
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