FORMER GLOBAL HEALTH AGENCY EXPERTS: 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 former U.S. Food and Drug Administration (FDA), EMA, MHRA, HPRA, and other global health authority professionals to add to its team of consultant professionals. The professional must have a strong background and demonstrable hands-on experience and skills.

Qualifications / Responsibilities include: 

• Various dosage forms including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms 
• Demonstrated regulatory compliance expertise of drug products and active pharmaceutical ingredients 
• SME’s on FDA, EMA, MHRA, and/or HPRA policies and procedures 
• Detailed knowledge of current Agency, ICH, and USP regulations / guidances and expectations, GXPs, and Food and Drug Law; interpretation and application of cGMP regulations 
• Pre-approval and post-market FDA and other Agency inspections; Post-market reviews, considerations, safety reporting, regulations and guidances; Pre-marketing requirements, activities, regulations and guidances 
• Pre-approval and pre-license inspection programs and compliance evaluations for ANDA, NDAs, and BLAs 
• Experience in performing GMP / GLP audits covering laboratory procedures and practices for Quality Control Laboratories; GMPs / GLPs / guidances and regulations; Laboratory QA 
• Data integrity requirements; electronic data reviews 
• GMPs for packaging, storage, and distribution of products 
• FDA 483, Warning Letter, Consent Decree remediation of complex matters 
• Remediation of laboratory control systems 
• Laboratory investigations including OOS and mitigation, deviations, and change control records 
• Quality Systems / Quality Assurance / Quality Control / Quality Standards 
• Regulatory filings 
• Drug review and approval process 
• Process validation 
• OOS investigations and change control 
• Supply chain controls 
• SOP and documentation practices; SOP development and reviews 
• Facilities and Equipment 
• Risk assessment process / application 
• Computer System validation 
• Microbiology 
• Training 
• Regulatory Affairs Experience (experience with DMF’s and ANDA’s for generic APIs and drug products is preferable) 
• Ability to lead projects and meet crucial timelines / project management 
• 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 (or equivalent) and 10 years’ relevant experience.