Cmc Compliance Head - Latam Internal Manufacturing

CMC Compliance Head LatAm Internal Manufacturing Added 26/10/2023Excellent opportunity to join a recognized company in the market.Excellent opportunity to your professional development.Our client is an international pharmaceutical company.Lead, coach, and supervise team members effectively; Develop regulatory CMC strategies in collaboration with stakeholders, ensuring alignment with project goals; Plan and coordinate cross-department efforts to secure and maintain Marketing Authorizations (MAs) for CMC topics efficiently and with high quality; Ensure the compliant execution of supervised medicinal product strategies, providing guidance for timely and high-quality regulatory compliance; Establish, review, and optimize global processes for product portfolio management in cooperation with stakeholders, leveraging expertise, benchmarking, innovation, and lean principles; Support GQA CMCprojects to ensure adherence to current standards and the timely, high-quality delivery of safe and dependable products to our patients; Oversee the timely preparation, review, and maintenance of CMC dossier sections in alignment with the plan; Provide operational guidance for CMC regulatory support, holding overall responsibility for the compliant supervised product portfolio, including change management; Manage financial planning and adherence, including operational expenses.Perfil idealDegree in Pharmaceutical Sciences or a related; At least 5 years of experience in CMC Regulatory and a Good Manufacturing Practices (GMP) environment.Proven leadership of virtual teams across multiple countries; Comprehensive knowledge of national and international regulatory guidelines and requirements, including EU, US, LatAm, and Japan; Excellent verbal and written communication skills in English, with proficiency in Spanish as an advantage; Strong communication, negotiation, and influencing skills; Global and service-oriented mindset with exceptional relationship management skills; Ability to perform effectively in challenging and constantly evolving environments.Excellent opportunity to your professional development.#J-18808-Ljbffr