Insud Pharma is a recognised 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 specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.
Chemo, 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. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti infectives, Respiratory, Women''s Health, Endocrinology, Dermatology and Urology).
We are selecting to work as a Regulatory Affairs Associate at Laboratorios Liconsa (Chemo).
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 for submission and follow up until product approval and launch, or change implementation. Organizes regulatory information, logs, and tracking. Ensures issuing AUTOS according to approved MA.
Specific Responsibilities
* Stay updated on changes in legislation and regulations and advise on the potential impact to product registration, marketing, manufacturing, or development.
* Advise the R&D team on Regulatory requirements for registration dossiers.
* Compile required information for registration dossiers.
* Submit registration and follow up with Health Authorities and Licensees until product approval and launch. Collaborate with the post marketing team to achieve the objective for launching any product.
* Coordinate and prepare answers to deficiency letters received from Health Authorities.
* Maintain regulatory files/database and chronologies in good order. Establish and maintain a system for tracking changes in documents submitted to agencies or licensees.
* Collaborate with Technical Admin RA in reviewing product labeling for compliance with regulatory requirements.
* Review and advise on product changes for impact on regulatory filings worldwide.
* Provide technical support to the sales department with the technical requirements of customers.
* Serve as regulatory liaison throughout the product lifecycle.
* Represent regulatory interests to marketing, R&D teams, and regulatory agencies.
* Submit dossiers during first submission waves.
* Collaborate on new opportunities: submission of new dossiers (EU/out of EU) and submission of portfolio products.
* Conduct audits.
Requirements
1. Education: Degree in Pharmacy, Chemistry, or Biology. Masters degree is a plus.
2.