Bioequivalence Expert - PK/PD & Regulatory Submissions

Pharmavise Corporation; United States; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Job summary

Pharmavise Corporation seeks a bioequivalence expert to provide consultation on study design, conduct, and interpretation for pharmaceutical clients. You will review protocols and SAPs to ensure regulatory compliance (FDA/EMA/ICH) and oversee PK analyses using WinNonlin or SAS.

Collaboration with regulatory, clinical and QA teams is essential to deliver robust bioequivalence programs. The role requires an advanced degree in pharmaceutical sciences or PharmD with at least 5 years of related

Qualifications

• Advanced degree in pharmaceutical sciences or PharmD with bioequivalence focus.
• Minimum 5 years in bioequivalence study design and conduct.
• Strong PK/PD modeling, regulatory knowledge, and global market familiarity.

Responsibilities

• Provide expert consultation in bioequivalence study design, conduct, analysis and interpretation.
• Review SAPs, protocols, and study reports for regulatory compliance (FDA, EMA, ICH).
• Design and oversee bioequivalence studies for generic products and select study designs.
• Perform PK and statistical analyses using WinNonlin or SAS.
• Prepare regulatory submissions and responses for bioequivalence data.
• Advise on bioanalytical method development and validation for PK studies.
• Stay updated on regulatory requirements and best practices in bioequivalence.
• Collaborate with regulatory, clinical development and quality teams for program success.

Skills

Bioequivalence

Study design

Statistical analysis

WinNonlin

SAS

PK/PD modeling

Regulatory knowledge

Communication skills

Regulatory affairs

Education

PhD in pharmaceutical sciences

PharmD

Equivalent degree

Tools

WinNonlin

SAS

Job description

Pharmavise Corporation seeks a bioequivalence expert to provide consultation on study design, conduct, and interpretation for pharmaceutical clients. You will review protocols and SAPs to ensure regulatory compliance (FDA/EMA/ICH) and oversee PK analyses using WinNonlin or SAS.

Collaboration with regulatory, clinical and QA teams is essential to deliver robust bioequivalence programs. The role requires an advanced degree in pharmaceutical sciences or PharmD with at least 5 years of related