Descripción de la oferta
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. #weareSRC 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. #netZeroCommitment 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.
