Bioequivalence Expert Pharmaceutical Consultant

Job Summary

This is a remote position.

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

Responsibilities

• 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.

Qualifications

• 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 (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.

This is a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development. Be part of our network of Subject Matter Experts.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.