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!
Major Tasks:
* 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.
* Work closely with Regulatory to develop effective Regulatory and CMC strategies.
* 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.
* Effectively manage post-approval change and product lifecycle.
* Drive continuous improvement.
* Maintain and implement knowledge of current industry requirements and best practices for CTD Module 3 and QoS or equivalent.
Requirements:
* Academic background in life sciences.
* Very high proficiency in spoken and written English, as this is a global position.
* Significant experience in CMC/Module 3 creation and response to questions.
* 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.
Offered:
* 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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