Regulatory Affairs Specialist
hace 18 horas
Insud Pharma, S.L.U. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth launch of our products in the market.
Key Responsibilities:- Compile and manage registration dossiers and coordinate with marketing authorization holders and post-marketing teams for submission and follow-up until product approval and launch.
- Stay updated on changes in legislation and regulations and advise on the potential impact on product registration, marketing, manufacturing, or development.
- Collaborate with R&D teams on regulatory requirements for registration dossiers and compile required information for registration submissions.
- Maintain regulatory files and databases in good order and establish systems for tracking changes in documents submitted to agencies or licensees.
- Provide technical support to the sales department and serve as a regulatory liaison throughout the product lifecycle.
- Education: Degree in Pharmacy, Chemistry, or Biology. Master's degree is a plus.
- Languages: Fluent Spanish and English. Knowledge of other languages is an asset.
- Experience: 3-6 years of experience in regulatory affairs or a related field.
- Specific knowledge: Good understanding of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossier CTD format content.
Insud Pharma, S.L.U. offers a dynamic and challenging work environment with opportunities for growth and development. We are committed to equal opportunities and treatment between men and women and do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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