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Regulatory Head Brazil: Strategic Leadership

2 meses atrás

São Paulo, São Paulo, Brasil SteinCares Tempo inteiro

Job Summary

SteinCares seeks a seasoned Regulatory Head to lead our Brazilian regulatory area, ensuring timely submissions, maintenance, and renewals. This role requires a strategic leader who can drive business growth while maintaining compliance.

Key Responsibilities

  • Lead the Brazilian regulatory and quality departments, fostering a culture of excellence and innovation.
  • Develop and implement regulatory strategies to accelerate market launches, leveraging expertise in compliance and quality processes.
  • Manage relationships with suppliers and regulatory authorities, ensuring seamless documentation and registration processes.
  • Oversee the management of sanitary registrations and brand registrations for SteinCares' products in Brazil, ensuring compliance with legal provisions.
  • Stay up-to-date on regulatory developments, providing expert guidance to the team and stakeholders.
  • Collaborate with commercial teams to drive business growth, targeting patients with innovative Biological, Biotechnological, Synthetic Products, and Therapeutic Devices.

Requirements

  • Pharmacy degree required; 5 years of experience in regulatory intelligence, including leading teams and managing regulatory affairs.
  • Proven track record in regulatory experience with pharma, innovators, and niche - Biologics.
  • Excellent communication skills, with oral English required and Spanish desirable.