Job Description:
About us: Insud Pharma is a recognized and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and over 7,000 employees across 50 countries. We specialize in the research, development, manufacture, and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, part of the Insud Pharma group, is a world leader in R&D and manufacturing of over 100 active pharmaceutical ingredients and more than 122 medicines, offering over 200 different product presentations. Chemo produces its own APIs and finished pharmaceutical products covering main therapeutic areas including Cardiology, Gastroenterology, CNS, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology, and Urology.
Commitment to Equal Opportunities: Insud Pharma is committed to equal opportunities and treatment regardless of ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances, in line with current legislation.
Position:
Regulatory Affairs Associate at Laboratorios Liconsa (Chemo)
Global Responsibilities:
* Manage registration dossiers and variation packages, coordinating with marketing authorization holders and post-marketing teams for submission, follow-up, approval, and launch.
* Organize regulatory information, logs, and tracking systems.
* Ensure issuance of AUTOS according to approved MA.
Specific Responsibilities:
* Stay updated on legislative and regulatory changes and advise on their impact.
* Guide R&D teams on regulatory requirements for dossiers.
* Compile information for registration dossiers.
* Submit registration dossiers and follow up with health authorities until approval and launch.
* Coordinate responses to deficiency letters from health authorities.
* Maintain regulatory files and tracking systems.
* Review product labeling for compliance.
* Advise on product changes affecting regulatory filings worldwide.
* Provide technical support to sales regarding regulatory requirements.
* Act as regulatory liaison throughout the product lifecycle.
* Represent regulatory affairs in submissions and audits.
* Collaborate on new dossier submissions globally.
Requirements:
* Degree in Pharmacy, Chemistry, or Biology; Master’s degree is a plus.
* Fluent in Spanish and English; knowledge of additional languages is an asset.
* At least 1 year of experience in regulatory affairs.
* Strong knowledge of pharmaceutical legislation, GMP, ICH guidelines, and CTD format.
* Proficiency in standard software tools.
* Occasional travel may be required.
Benefits:
* Life and accident insurance.
* Access to online training and library resources.
* Well-being platform for social, physical, and emotional health.
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