Cmc Regulatory Affairs Specialist (Big Pharma)

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 :

Offered :

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