Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking accomplished Regulatory Biosimilars experts (per diem). The Biosimilars Regulatory professional must have a strong background and demonstrable hands-on experience and skills.

Qualifications / Responsibilities include:

• Global Regulatory CMC strategy development / implementation for Biosimilars
• Development of CMC and analytical dossiers for biosimilar product registration
• Analytical / critical reviews of biosimilar regulatory documentation
• Deep understanding of FDA regulatory guidance for biosimilars, including technical / CMC guidance
• US and global regulatory requirements; US and global product labeling requirements
• Biosimilar US FDA / global applications / submissions and supplement reviews
• FDA liaison experience
• Product lifecycle Regulatory expertise (development, launch, post-approval, and lifecycle)
• Identification / mitigation of regulatory risks
• Pharmacovigilance / drug safety
• Bioavailability / bioequivalence expertise
• Bioequivalence studies
• Biopharmaceutics and Regulatory science
• Biotechnology experience
• GCP and GLP audits
• Formulation development; dissolution methods/reviews; interpretation of dissolution data
• Study design and protocol development
• Pharmacokinetic, pharmacodynamic, and clinical endpoint studies
• Bioanalytical method validation
• Statistical data analyses
• Due diligence reviews of bioequivalence reports
• Ability to lead projects and meet crucial timelines
• Superb written and oral communication skills
• Excellent interpersonal and soft skills
• Ability to solve problems using innovative techniques

Educational / Experience Requirements include:

• B.S. life sciences and 10 years’ relevant experience.

For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available.  Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective, and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable, and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.