Direct message the job poster from Synthon MéxicoWe are looking for aQuality and Regulatory Affairs DirectorinSynthon México:A Senior Executive with more than 15 years of experience in the pharmaceutical industry, specialized incontrolled, biosimilar and bioequivalent products, with a solid track record intotal quality management (TQM)and compliance withnational and international regulatory regulations.
With an extensive international exposure leading operation in highly regulated markets such asthe U.S. (FDA), Europe (EMA), Japan (PMDA)andLatin America (COFEPRIS, ANVISA, INVIMA).
You would be responsible for theclinical area, with experience in the design, implementation and monitoring of clinical studies for biopharmaceutical and controlled products, ensuring compliance with GCP and local and international ethical regulations.
Leading expertise in the development and implementation ofglobal regulatory strategies, design ofrobust quality systems under GxP STANDARDS (GMP, GDP, GLP),and implementationof risk management systemsin accordance withICH Q9.
Proven track record in obtaining and maintaininghealth registrationsfor complex pharmaceutical products, includingbiologics, biosimilars, and high-surveillance molecules.With the ability to leadregulatory audits(FDA, EMA, COFEPRIS), managemultidisciplinary teamsin multicultural environments and ensure thestrategic alignmentof quality with business objectives.
Strong focus oncompliance, regulatory innovation, organizational development and operational efficiency.Ensure products and processes comply with quality standards by establishing and enforcing quality requirements.Prepare quality reports of processes and products by collecting, analyzing, and summarizing information and trends.Serve as the main point of contact with COFEPRIS and lead scientific advice/consultation meetings with regulatory authorities.
Responsible for obtaining Sanitary Registrations.Lead the development and implementation of regulatory strategies to secure product commercialization.Establish the renewal schedule for registrations and new products.Ensure Pharmacovigilance (PV) activities are conducted in accordance with all applicable regulations.Lead the development of Risk Management Plans, their implementation, and assessment of effectiveness.Design response strategies for inquiries from ethics committees and health authorities regarding safety.Act as Qualified Person (Responsable Sanitario) for the QC Laboratory and head of the clinical area.Budget management and control.KPI management and control.Responsible for: Quality Systems; Metrology and Validation, Quality Assurance, Sanitary Registration, Regulatory Affairs & Pharmacovigilance, Laboratory ControlQuality Global Strategy AlignmentSoft SkillsBusiness acumenFlexibility and adaptabilityComplex problem solvingAccountability and responsible leadership.Requirements5 to 10 years of previous experience as a Quality Manager or Regulatory Affairs HeadBachelor's Degree in Pharmaceutical Chemist Biologist (preferably)Professional English is requiredRequired to reside in México CityAvailability to travel to Guadalajara for 2 weeks per month.If you meet the requirements above, apply nowSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and Product ManagementIndustriesPharmaceutical Manufacturing and Wholesale Drugs and SundriesReferrals increase your chances of interviewing at Synthon México by 2xSign in to set job alerts for "Director Quality Regulatory Affairs" roles.Director, Sr.
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