Bioequivalence Expert Pharmaceutical Consultant
3 weeks ago
This is a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development.
Job Summary:We are seeking a highly skilled Bioequivalence Expert Pharmaceutical Consultant to join our team at Pharmavise Consulting Corp. The ideal candidate will have a deep understanding of bioequivalence principles, study methodologies, and regulatory requirements in major markets.
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.
- 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.
- 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.
- 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 competitive compensation package opportunity for individuals passionate about bioequivalence and generic drug development.
Pharmavise Consulting Corp. is an equal opportunity employer and does not discriminate on the basis of race, color, religion, creed, sex, 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.
-
Bioequivalence Expert Pharmaceutical Consultant
3 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Bioequivalence Expert Pharmaceutical ConsultantThis is a remote position that offers a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development.About the Role:We are seeking a highly skilled Bioequivalence Expert Pharmaceutical Consultant to join our team at Pharmavise Consulting Corp. As a...
-
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob DescriptionThis is a remote position that requires expertise in bioequivalence study design, conduct, analysis, and interpretation for pharmaceutical companies and contract research organizations (CROs).Responsibilities:Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation.Review study protocols,...
-
Pharmaceutical Safety Consultant
2 months ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob SummaryWe are seeking a highly skilled Pharmaceutical Safety Consultant to join our team at Pharmavise Corporation. As a key member of our regulatory compliance team, you will be responsible for providing expert consultation and support in drug safety and pharmacovigilance to pharmaceutical companies and regulatory agencies.Key ResponsibilitiesDrug...
-
Drug Safety Pharmaceutical Consultant
4 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Drug Safety Pharmaceutical ConsultantThis is a challenging and rewarding opportunity for individuals passionate about drug safety and patient well-being. As a Drug Safety Pharmaceutical Consultant, you will be responsible for providing expert consultation and support in drug safety and pharmacovigilance to pharmaceutical companies and regulatory...
-
Regulatory Expert
1 month ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeRegulatory Expert OpportunityWe are seeking a highly skilled Regulatory Expert to join our team at Pharmavise Consulting Corp. As a Regulatory Expert, you will provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and...
-
Regulatory Affairs Biosimilars Consultant
1 month ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeRegulatory Affairs Biosimilars ConsultantThis is a remote position that offers a unique opportunity for biosimilars consultant professionals to leverage their regulatory expertise on biologic medical products and make a meaningful impact in the pharmaceutical and medical device industries.Responsibilities:Provide expert regulatory affairs guidance and...
-
Regulatory Expert
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeWe are seeking a highly skilled Regulatory Expert to join our team at Pharmavise Consulting Corp. As a Regulatory Expert, you will provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval.Responsibilities:Provide regulatory guidance...
-
Homeopathic Per Diem Consultant
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeThis is a remote position with Pharmavise Consulting Corp., a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device, and Biotechnology clients.We are seeking a Homeopathic Per Diem Consultant to provide expert consultation and guidance on homeopathic treatments and remedies to clients/patients.The ideal candidate will have...
-
Regulatory Affairs Biosimilars Consultant
1 month ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Regulatory Affairs Biosimilars ConsultantPharmavise Consulting Corp. is seeking a highly skilled Regulatory Affairs Biosimilars Consultant to join our team. As a key member of our regulatory compliance team, you will provide expert guidance and support for biosimilars development projects.Responsibilities:Provide regulatory affairs guidance and...
-
Homeopathic Per Diem Consultant
2 months ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Summary:We are seeking a highly skilled Homeopathic Per Diem Consultant to join our team at Pharmavise Consulting Corp. As a Homeopathic Per Diem Consultant, you will provide expert consultation and guidance on homeopathic treatments and remedies to clients/patients.Key Responsibilities:Conduct thorough assessments of clients' health conditions, medical...
-
Cell Therapy Expert
4 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeCell Therapy Expert - Full TimeThis is a remote position that offers a unique opportunity to work with a leading regulatory compliance consulting firm, Pharmavise Consulting Corp. Our team values Excellence Through Quality and is dedicated to providing solutions to complex compliance issues in the pharmaceutical, medical device, and biotechnology...
-
Regulatory Expert
4 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Regulatory ExpertThis is a remote position that requires a high level of expertise in regulatory affairs. We are seeking a talented and experienced professional with a deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval.Responsibilities:Provide...
-
Gene Therapy Expert
4 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeGene Therapy Expert - Full TimeThis is a remote position that requires a highly skilled and knowledgeable professional to join our team as a Gene Therapy Expert - Full Time. We are seeking an individual with a strong background in gene therapy research and development, as well as experience in vector design, optimization, and...
-
Regulatory Affairs Biosimilars Consultant
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeThis is a remote position that requires expertise in regulatory affairs for biosimilars development projects. The ideal candidate will have a strong understanding of regulatory requirements and guidelines governing biosimilars development and approval processes.Responsibilities:Provide expert regulatory affairs guidance and support for biosimilars...
-
Cell Therapy Expert
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeCell Therapy Expert - Full TimeThis is a remote position that offers a unique opportunity to work with a leading regulatory compliance consulting firm, Pharmavise Consulting Corp. We partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues.Responsibilities:Lead and contribute to cell therapy...
-
Homeopathic Per Diem Consultant
1 month ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Homeopathic Per Diem ConsultantThis is a remote position that offers flexible scheduling arrangements based on consultant availability and client demand.Job Summary:Pharmavise Consulting Corp. is seeking a highly skilled Homeopathic Per Diem Consultant to join our team. As a Homeopathic Per Diem Consultant, you will provide expert consultation and...
-
Gene Therapy Expert
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Gene Therapy Expert - Full TimeWe are seeking a highly skilled Gene Therapy Expert to join our team at Pharmavise Consulting Corp. As a Gene Therapy Expert, you will be responsible for leading and contributing to gene therapy research and development projects from early discovery through to clinical development.Responsibilities:Design and execute...
-
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob DescriptionPharmavise Consulting Corp. is seeking a highly skilled and experienced Regulatory Expert to join our team as a Former FDA Expert. This is a unique opportunity for professionals with a background in regulatory affairs to leverage their expertise and make a meaningful impact in the pharmaceutical and medical device...
-
Cell Therapy Expert
2 weeks ago
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob Title: Cell Therapy Expert - Full TimeWe are seeking a highly skilled Cell Therapy Expert to join our team at Pharmavise Consulting Corp. As a Cell Therapy Expert, you will be responsible for leading and contributing to cell therapy research and development projects aimed at advancing novel cellular therapies for various diseases and...
-
Maple Grove, Minnesota, United States Pharmavise Corporation Full timeJob DescriptionPharmavise Consulting Corp. is seeking experienced professionals with a background in regulatory affairs to join our team as Former FDA Experts. This is a unique opportunity to leverage your expertise and make a meaningful impact in the pharmaceutical and medical device industries.Responsibilities:Regulatory Guidance and Strategy: Provide...
