Were 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 general 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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