About Us: Insud Pharma is a recognized and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specializing in the research, development, manufacture, and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, the industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations.
Global Responsibility: Compiles and manages the Registration dossier or the Variation packages and coordinates with the Marketing Authorization Holders (licensees) and/or Post Marketing Team the submission and follow-up until product approval and launch, or change implementation. Organizes regulatory information, logs, and tracking. Ensure issuing AUTOS according to approved MA.
Specific Responsibilities:
1. Stay updated on changes in legislation and regulations and advise on the potential impact to product registration, marketing, manufacturing, or development.
2. Advise R&D team on Regulatory requirements for registration dossier.
3. Compile required information for registration dossiers.
4. Submit registrations and follow up with Health Authorities and Licensees until product approval and launch.
5. Collaborate with any submission with the post-marketing team to achieve objectives for launching any product.
6. Coordinate and prepare responses to deficiency letters received from Health Authorities.
7. Maintain regulatory files/database and chronologies in good order.
8. Establish and maintain a system for tracking changes in documents submitted to agencies or licensees.
9. Collaborate with Technical-Admin RA reviewing product labeling for compliance with regulatory requirements.
10. Review and advise on product changes for impact on regulatory filings worldwide.
11. Provide technical support to the sales department regarding the technical requirements of customers.
12. Serve as regulatory liaison throughout the product lifecycle.
13. Serve as regulatory representative to marketing, R&D teams, and regulatory agencies.
14. Submit dossiers during first submission waves.
15. Collaborate in new opportunities: submission of new dossiers (EU/out of EU) and submission portfolio products.
16. Participate in audits.
Requirements:
1. Education: Degree in Pharmacy, Chemistry, or Biology. Master’s is a plus.
2. Languages: Fluent in Spanish and English; knowledge of other languages will be an asset.
3. Experience: 1-4 years of experience in similar functions.
4. Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossier CTD format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).
5. Travel: Occasionally.
Become part of an expanding pharmaceutical company in which we offer:
* Life and accident insurance.
* Free online training platform.
* Free online library.
* Social, physical, and emotional well-being platform.
COMMITMENT TO EQUAL OPPORTUNITIES: Insud Pharma is committed to equal opportunities and treatment between men and women, as stated in current legislation, and does 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.
For the original announcement, please visit: Kit Empleo.
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