Bioequivalence Expert Pharmaceutical Consultant

Pharmavise Corporation; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

PharmaviseConsulting Corp. is seeking a senior Bioequivalence consultant to support BE study design, analysis, and regulatory submissions for pharmaceutical clients on a remote basis.

You will review SAPs, design BE studies, perform PK/PD analyses with WinNonlin or SAS, and collaborate with regulatory affairs, clinical development, and QA to ensure compliance in US and EU markets.

Qualifications

• Advanced degree in pharmaceutical sciences, pharmacokinetics, or related field.
• Minimum of 5 years of bioequivalence study design and conduct experience.
• Deep understanding of BE principles, study methodologies, and regulatory requirements in major markets (US, EU).
• Proficiency in PK/PD modeling and simulation techniques.
• Experience with bioanalytical method development and validation for PK studies.
• Strong analytical and problem-solving skills; ability to interpret complex PK data and statistical analyses.
• Excellent communication and presentation skills; ability to convey technical information to diverse audiences.

Responsibilities

• Provide expert consultation in BE study design, conduct, analysis, and interpretation to pharma companies and CROs.
• Review study protocols, SAPs, and reports to ensure regulatory compliance (FDA, EMA, ICH).
• Design and oversee BE studies for generic drug products, selecting study 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, BE study reports).
• Provide guidance on bioanalytical method development and validation for BE studies.
• Stay updated on regulatory requirements and best practices in BE and generic development.
• Collaborate with regulatory affairs, clinical development, and QA to ensure BE program success.

Skills

PK/PD modeling

Bioequivalence principles

Regulatory interpretation

Data analysis

Communication skills

Education

PhD or PharmD or equivalent

Tools

WinNonlin

SAS

Job description

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.

Visit us atwww.pharmavise.com

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 (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.

This is a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development.

Competitive compensation packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please . PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients.

When you joinPharmavise, you become part of a team that values Excellence Through Quality.

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Originally posted on Himalayas