We're currently seeking a talented RA CMC Specialist to join an innovative big pharma company located in the metropolitan area of Barcelona within its OTC business unit!
Support the development of the CMCD (Chemistry, Manufacturing, and Controls Development) strategy for certain products of the business unit, both mature and new launch, to ensure globally approvable dossiers.Responsibility is shared across global and local markets.Collaborate with R&D, Product Supply, and Regulatory to ensure the timely compilation of high-quality CTD Module 3 and QOS documents.Support responses to Quality questions from Regulatory Health Authorities.Very high proficiency in spoken and written English, as this is a global position.Experience in QA and RA departments for global markets, including but not limited to North America, South America, Europe, Australia, ASEAN, and the Middle East.Experience leading projects in the QA department.
Attractive compensation package with extensive social benefits.Hybrid position with great flexibility.You will belong to a leading big pharma company in its sector.
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