Fda Investigators And Reviewers

Pharmatech Associates is seeking former FDA investigators and reviewers to provide consultation and remediation services to our pharmaceutical, biologics and medical device clients. The nature of our projects varies from client to client and can often be supported remotely.

Typical Project Responsibilities Include

• Drafting or reviewing responses to FDA 483 observations, warning letters or similar documents
• Review draft submissions including but not limited to ANSA, NDA, and BLAs
• Preparing for, conducting, and reporting on mock pre-approval or post-approval FDA inspections and compliance evaluations in support of ANDA, NDAs, and BLA submissions
• Conduct gap assessment of quality management systems and provide prioritized remediation recommendations
• Participate in complex root cause investigations including manufacturing deviations and OOS investigations
• Evaluation of inspection readiness programs including providing recommendations for improvement
• Provide interpretation of GxP requirements for novel therapeutics
• Remediation of laboratory control systems
• Remediation planning for various dosage form manufacturing facilities including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms

Educational/Experience Requirements Include

• Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients
• Superb written and oral communication skills
• Excellent interpersonal and soft skills
• FDA Experience is required (investigator or reviewer)
• Familiarity or experience with reviewing regulatory filings and the drug, biologic or device review and approval process (DMFs, ANDAs, NDAs, BLAs, PMAs, etc.)
• Ability to lead projects, where required, manage work to a defined scope of work and meet crucial timelines
• Expert knowledge of current FDA, ICH, and USP laws, regulations, guidances and expectations.
• Ability to solve problems using innovative techniques
• B.S. life sciences and 10 years’ relevant experience

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.