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Trainee - regulatory affairs

Barcelona
Indefinido
JR Spain
Publicada el 1 agosto
Descripción

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REQUISITOS:

* NO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDAD

Who we are?

Veterinary medicine manufacturers

Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977.

In Vetpharma, we are a highly qualified team with extensive experience in development, registration, and marketing of veterinary medicinal products, APIs, and nutraceuticals.

Overview:

The role involves compiling and managing registration dossiers or variation packages, coordinating submissions, and following up until product approval, launch, or change implementation. Organizes regulatory information, logs, and tracking.

Responsibilities:

* Stay updated on legislative and regulatory changes, advising on their impact on registration, marketing, manufacturing, or development.
* Participate in product development and regulatory strategy for new products.
* Prepare, review, and approve protocols and reports from CMOs or CROs.
* Compile required information for registration dossiers and variations according to European legislation.
* Handle registration submissions and follow-up with health authorities until approval and launch.
* Coordinate and prepare responses to deficiency letters from health authorities.
* Maintain regulatory files, databases, and change tracking systems.

Qualifications:

* Education: University degree in life sciences (Veterinary, Pharmacy, Chemistry, or Biology). A master's degree is a plus.
* Languages: High proficiency in English is required; knowledge of other European languages is a plus.
* Experience: No prior experience required.
* Knowledge: Good understanding of pharmaceutical legislation, registration dossier formats, and proficiency with standard software tools (Word, Excel, PowerPoint, Project).
* Travel: Occasional travel expected.
* Personal Skills: Good communication, teamwork, results-oriented, autonomous, creative, entrepreneurial.

Additional Benefits:

* Flexible start time (Monday to Friday, full-time).
* Life and accident insurance.
* Benefits and savings club.
* Training and language learning platform.
* Wellness platform with free psychologist sessions.
* Cabify transportation service.
* Development and internal mobility policies.

Selection Process:

Stay tuned via phone and email. The process may include interviews (virtual or in-person) and possibly tests. We aim to keep you informed throughout.

Interested? Follow us on social media like LinkedIn and Instagram for updates and opportunities to join Insud Pharma.

Commitment to Equal Opportunities:

Insud Pharma is committed to equality and non-discrimination based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or social circumstances, in line with Organic Law 3/2007.

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