Overview: About us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and over 7,000 employees in 50 countries.
We specialise 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 over 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.
COMMITMENT TO EQUAL OPPORTUNITIES: Insud Pharma is committed to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007.
We 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.
Responsibilities: Global Responsibility: Compiles and manages the Registration dossier or 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.
Ensures issuing AUTOS according to approved MA.
Specific Responsibilities: Stay updated on changes in legislation and regulations and advise on the potential impact to the product registration, marketing, manufacturing, or development.
Advise R&D team on Regulatory requirements for registration dossier.
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 deficiencies 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 reviewing product labelling 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 the customers.
Serve as regulatory liaison throughout the product lifecycle.
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