Bioequivalence Expert, Pharmaceutical Consultant
Job Description:
• Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation to pharmaceutical companies and contract research organizations (CROs).
• Review study protocols, statistical analysis plans (SAPs), and study reports to ensure compliance with regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Design and oversee bioequivalence studies for generic drug products, including selection of appropriate study designs, endpoints, and statistical methods.
• Conduct pharmacokinetic (PK) and statistical analyses of bioequivalence data using software such as WinNonlin or SAS.
• Prepare and review bioequivalence sections of regulatory submissions, including abbreviated new drug applications (ANDAs), bioequivalence study reports, and responses to regulatory inquiries.
• Provide guidance on bioanalytical method development and validation for bioequivalence studies.
• Stay abreast of emerging regulatory requirements, scientific advancements, and best practices in bioequivalence and generic drug development.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and quality assurance, to ensure successful execution of bioequivalence programs.
Requirements:
• Advanced degree (PhD, PharmD, or equivalent) in pharmaceutical sciences, pharmacokinetics, or related field.
• Minimum of 5 years of experience in bioequivalence study design and conduct within the pharmaceutical industry, CRO, or regulatory agency.
• Deep understanding of bioequivalence principles, study methodologies, and regulatory requirements in major markets (e.g., US, EU).
• Proficiency in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation techniques.
• Experience with bioanalytical method development and validation for PK studies.
• Strong analytical and problem-solving skills, with the ability to interpret complex PK data and statistical analyses.
• Excellent communication and presentation skills, with the ability to effectively convey technical information to diverse audiences.
• Regulatory affairs certification (RAC) or relevant professional certification (e.g., DABT, CCRP) preferred but not required.
Benefits:
• Competitive compensation packages are available
• Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation to pharmaceutical companies and contract research organizations (CROs).
• Review study protocols, statistical analysis plans (SAPs), and study reports to ensure compliance with regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Design and oversee bioequivalence studies for generic drug products, including selection of appropriate study designs, endpoints, and statistical methods.
• Conduct pharmacokinetic (PK) and statistical analyses of bioequivalence data using software such as WinNonlin or SAS.
• Prepare and review bioequivalence sections of regulatory submissions, including abbreviated new drug applications (ANDAs), bioequivalence study reports, and responses to regulatory inquiries.
• Provide guidance on bioanalytical method development and validation for bioequivalence studies.
• Stay abreast of emerging regulatory requirements, scientific advancements, and best practices in bioequivalence and generic drug development.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and quality assurance, to ensure successful execution of bioequivalence programs.
Requirements:
• Advanced degree (PhD, PharmD, or equivalent) in pharmaceutical sciences, pharmacokinetics, or related field.
• Minimum of 5 years of experience in bioequivalence study design and conduct within the pharmaceutical industry, CRO, or regulatory agency.
• Deep understanding of bioequivalence principles, study methodologies, and regulatory requirements in major markets (e.g., US, EU).
• Proficiency in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation techniques.
• Experience with bioanalytical method development and validation for PK studies.
• Strong analytical and problem-solving skills, with the ability to interpret complex PK data and statistical analyses.
• Excellent communication and presentation skills, with the ability to effectively convey technical information to diverse audiences.
• Regulatory affairs certification (RAC) or relevant professional certification (e.g., DABT, CCRP) preferred but not required.
Benefits:
• Competitive compensation packages are available