We are looking for a Quality and Regulatory Affairs Director in Synthon México:
A Senior Executive with more than 15 years of experience in the pharmaceutical industry, specialized in controlled, biosimilar and bioequivalent products, with a solid track record in total quality management (TQM) and compliance with national and international regulatory regulations. With an extensive international exposure leading operation in highly regulated markets such as the U.S. (FDA), Europe (EMA), Japan (PMDA) and Latin America (COFEPRIS, ANVISA, INVIMA).
You would be responsible for the clinical 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 of global regulatory strategies, design of robust quality systems under GxP STANDARDS (GMP, GDP, GLP), and implementation of risk management systems in accordance with ICH Q9. Proven track record in obtaining and maintaining health registrations for complex pharmaceutical products, including biologics, biosimilars, and high-surveillance molecules.
With the ability to lead regulatory audits (FDA, EMA, COFEPRIS), manage multidisciplinary teams in multicultural environments and ensure the strategic alignment of quality with business objectives. Strong focus on compliance, regulatory innovation, organizational development and operational efficiency.
Key Competencies:
- 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 Control
- Quality Global Strategy Alignment
Soft Skills:
- Business acumen
- Flexibility and adaptability
- Complex problem solving
- Accountability and responsible leadership.
Requirements:
- 5 to 10 years of previous experience as a Quality Manager or Regulatory Affairs Head
- Bachelor's Degree in Pharmaceutical Chemist Biologist (preferably)
- Professional English is required
- Required to reside in México City
- Availability to travel to Guadalajara for 2 weeks per month.
If you meet the requirements above, apply now!