MFC-2411-401DIRECTOR OF QUALITY AND REGULATORY NUTRACEUTICALSMADRIDJob Summary:The Director of Quality and Regulatory Affairs will oversee all quality assurance and regulatory compliance activities for the company's pharmaceutical products worldwide.
This includes ensuring adherence to global regulatory standards such as those set by the FDA, EFSA, TGA, and WHO while driving continuous improvement in the company's Quality Management System.This role requires strategic leadership, detailed regulatory expertise, and the ability to manage cross-functional, international teams.
The Director will lead critical initiatives, from regulatory submissions to quality certifications, ensuring the company's products consistently meet the highest standards of safety, efficacy, and compliance.Key Responsibilities:Regulatory Compliance:Ensure all pharmaceutical products meet global regulatory requirements, including FDA, EFSA, TGA, and GMP standards.Monitor regulatory changes worldwide, assess their impact, and guide company adaptation.Oversee the compliance and improvement of the Quality Management System (QMS).Documentation and Approvals:Prepare and submit regulatory documents for product approvals, renewals, and notifications across global markets.Maintain accurate and comprehensive records of regulatory submissions and communications.Quality Assurance:Lead the implementation and maintenance of robust quality assurance processes to ensure product safety and efficacy.Oversee and manage internal and external audits, inspections, and quality control processes.Develop and uphold certifications such as ISO 9001, ISO 14001, and ISO 22000.Labeling and Marketing Compliance:Review and approve product labeling, packaging, and marketing materials to ensure compliance with regional and global regulatory standards.Team Leadership:Lead, mentor, and develop an international team of regulatory and quality professionals.Establish and track KPIs for quality assurance and regulatory activities to drive continuous improvement.Qualifications:Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field; an advanced degree is strongly preferred.10–15+ years of experience in regulatory affairs and quality assurance within the pharmaceutical industry.In-depth knowledge of global pharmaceutical regulatory frameworks (e.g., FDA, EFSA y TGA) and quality standards (e.g., GMP, ISO).Proven experience leading and managing international and cross-functional teams.Strong organizational, analytical, and problem-solving skills.Fluent in English and Spanish, with excellent verbal and written communication abilities.Demonstrated ability to excel in a fast-paced and dynamic environment.
#J-18808-Ljbffr