Regulatory Affairs Specialist
hace 17 horas
Insud Pharma, S.L.U. is a leading pharmaceutical company with over 40 years of experience in the research, development, manufacture, and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.
Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and guidelines, managing registration dossiers, and coordinating with health authorities and licensees.
Key Responsibilities- Compile and manage registration dossiers and variation packages
- Coordinate with marketing authorization holders and post-marketing teams
- Organize regulatory information, logs, and tracking
- Ensure issuing of AUTOS according to approved MA
- Stay updated on changes in legislation and regulations
- Advise and give interpretation on potential impact to product registration, marketing, manufacturing, or development
- Degree in Pharmacy, Chemistry, or Biology
- Master's degree is a plus
- Fluent Spanish and English, knowledge of other languages is an asset
- 3-6 years of experience in regulatory affairs
- Very good knowledge of general pharmaceutical legislation and regulations
Insud Pharma, S.L.U. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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