P We#39;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! /p pb Major Tasks: /b /pulli 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. /lili Responsibility is shared across global and local markets. /lili Work closely with Regulatory to develop effective Regulatory and CMC strategies. /lili Collaborate with RD, Product Supply, and Regulatory to ensure the timely compilation of high-quality CTD Module 3 and QOS documents. /lili Support responses to Quality questions from Regulatory Health Authorities. /lili Effectively manage post-approval change and product lifecycle. /lili Drive continuous improvement. /lili Maintain and implement knowledge of current industry requirements and best practices for CTD Module 3 and QoS or equivalent. /li /ul pb Requirements: /b /pulli Academic background in life sciences. /lili Very high proficiency in spoken and written English, as this is a global position. /lili Significant experience in CMC/Module 3 creation and response to questions. /lili 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. /lili Experience leading projects in the QA department. /li /ul pb Offered: /b /pulli Attractive compensation package with extensive social benefits. /lili Hybrid position with great flexibility. /lili You will belong to a leading big pharma company in its sector. /li /ul pb#weareSRC /b /pp Randstad promotes equal employment opportunities through diverse and inclusive teams. Therefore, in our processes, we guarantee the inclusion of all people regardless of their personal condition, gender, sexual orientation, ethnicity, culture, age, religion or disability. /p pb#netZeroCommitment /b /pp Randstad encourages you to reduce your environmental impact to make your environment a better place for everyone. Our commitment to the Science Based Targets (SBTi) initiative, whose targets are based on science, drives Randstad ambition to be Net Zero by 2050. /p