Remote Bioequivalence Expert & Regulatory Strategist

Pharmavise Corporation; Poland; Remote; PLN 240,000 - 320,000; Full time

Job summary

Pharmavise Consulting Corp. is a regulatory compliance consulting firm partnering with Pharmaceutical, Medical Device and Biotechnology clients to resolve complex compliance issues. This remote role focuses on bioequivalence study design, data analysis, and regulatory submissions for global markets.

Join a team that emphasizes scientific excellence, regulatory insight, and collaboration across QA, regulatory affairs, and clinical development to deliver BE programs for generics.

Qualifications

• Advanced degree in pharmaceutical sciences, pharmacokinetics or related field.
• Minimum of 5 years BE study design and conduct experience in pharma, CRO, or regulator.
• Deep understanding of BE principles and regulatory requirements (US/EU).
• Proficiency in PK/PD modeling and simulation.

Responsibilities

• Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation.
• Review study protocols, SAPs, and study reports to ensure regulatory compliance (FDA, EMA, ICH).
• Design and oversee BE studies for generic drug products, selecting designs, endpoints, and methods.
• Conduct PK and statistical analyses of BE data using WinNonlin or SAS.
• Prepare and review BE sections of regulatory submissions (ANDAs) and responses.
• Guide bioanalytical method development and validation for BE studies.
• Stay updated on regulatory requirements, scientific advancements and best practices.
• Collaborate with cross-functional teams to ensure BE program success.

Skills

Bioequivalence design

Bioequivalence analysis

PK/PD modeling

WinNonlin

SAS

Regulatory submissions

Regulatory compliance

Education

PhD/PharmD or equivalent

Tools

WinNonlin

SAS

Job description

Pharmavise Consulting Corp. is a regulatory compliance consulting firm partnering with Pharmaceutical, Medical Device and Biotechnology clients to resolve complex compliance issues. This remote role focuses on bioequivalence study design, data analysis, and regulatory submissions for global markets.

Join a team that emphasizes scientific excellence, regulatory insight, and collaboration across QA, regulatory affairs, and clinical development to deliver BE programs for generics.