Knight Therapeutics Brasil is seeking a highly experienced and motivated Bioequivalence Manager to lead our bioequivalence studies for branded generics in Latin America. The successful candidate will oversee the strategy, design, implementation, and analysis of bioequivalence studies to ensure compliance with regional regulatory requirements and support the development and approval of branded generic products tailored for the Latin American market.

• Leadership
  • Lead and manage internal and/or external teams of scientists and research associates in conducting bioequivalence studies, focusing on Latin American markets.
  • Develop and implement strategic plans to achieve bioequivalence study objectives specific to Latin America.
  • Develop mitigation and contingency plans to optimize operations.
  • Perform evaluation for due diligence opportunities.
  • Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and clinical operations, to support the development of branded generics for the region.
• Bioequivalence Studies
  • Design and oversee bioequivalence study protocols in compliance with regional regulatory guidelines (e.g., ANVISA, COFEPRIS, INVIMA).
  • Ensure the accurate and timely execution of studies, including the management of timelines, monitoring activities, budgets, and resources.
  • Analyze and interpret study data, providing scientific input and recommendations for branded generics in Latin America.
• Regulatory Compliance
  • Ensure all bioequivalence activities comply with Latin American regulatory requirements, ICH and standards.
  • Prepare and review regulatory submissions related to bioequivalence studies for branded generics in the region.
  • Serve as the primary point of contact with regional regulatory agencies regarding bioequivalence issues.
  • Monitor regulatory environment and assess the business impact.
• Market-Specific Expertise
  • Stay informed of industry trends and advancements in bioequivalence methodologies and technologies relevant to Latin America.
  • Provide scientific leadership and guidance to the team and organization, with a focus on the Latin American markets.
  • Represent the company at scientific conferences and industry meetings in Latin America.
• Collaboration and Communication
  • Foster strong relationships with internal and external stakeholders, including contract research organizations (CROs) and academic partners in Latin America.
  • Communicate study results and progress to senior management and relevant stakeholders, emphasizing regional market implications.

• Minimum of 7 years of experience in bioequivalence studies within the pharmaceutical industry, with a focus on Latin America.
• Experience in identification and management of CROs / 3rd parties for Pharmaceutical Equivalence studies.
• Negotiation of contracts / schedules for bioequivalent studies.
• Feasibility of bioequivalent studies (identification of risks during due diligence).
• Experience in meeting and negotiation with Health Authorities.
• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field (Master's or Ph.D. preferred).
• In-depth knowledge of regional regulatory requirements and guidelines for bioequivalence studies in Latin America.
• Knowledge of Clinical strategy and planning.
• In-depth knowhow on developing strategy / approach on pilot and pivotal BE studies.
• Ability to integrate with the development team (formulation and analytical teams) for coordination of data driving the clinical strategy.
• Proven experience in leading and managing scientific teams.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills in both English and Spanish (Portuguese is a plus).
• Ability to work collaboratively in a fast-paced environment, with cultural awareness of the Latin American market.
• Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address development challenges.