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Regulatory Affairs Specialist
beBeeRegulatoryBarcelona, ESHace 10 días
Descripción del trabajoExperience in authoring and reviewing dossiers Proven regulatory experience and post-approval maintenance (including product labeling and CMC activities) In-depth knowledge of ICH guidelines Familiarity with the fundamental principles of regulatory affairs Excellent communication skills and ability to work collaboratively as part of a team
Regulatory Affairs Specialist Role
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Spain. This exciting opportunity is perfect for an ambitious and eager professional looking to expand their expertise in regulatory affairs.
Your key responsibilities will include :
- Preparing and compiling high-quality regulatory submissions for medicinal products in the EU and ROW
- Creating accurate and comprehensive CMC documents
- Reviewing artwork and promotional materials to ensure compliance
- Providing regulatory guidance, advice, and input into submission strategies for new and established products
- Communicating effectively with regulatory agencies
To succeed in this role, you will need :
As a Regulatory Affairs Specialist, you will have the opportunity to develop your skills and contribute to the success of our company.
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Regulatory Specialist • Barcelona, ES