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Post : Regulatory Affairs Specialist
Job Summary
To support Lonza, Houston Regulatory Affairs department by providing regulatory support to the site and to customers for cell and gene therapy programs. Regulatory affairs technical expert. Anticipation, evaluation and implementation of trends and innovations in the area of expertise. This individual will be responsible for designing and implementing models and templates and for gathering and assembling CMC documents and information for submission based on those models. Strong analytical, organizational and communication skills are essential. Reporting to the Head of Regulatory Affairs, Houston will support the site and customer related Regulatory Affairs (RA) and CMC project activities.
Job Duties:
• Provides technical writing, review, editing, and formatting of drafts and related materials for CMC sections of regulatory applications.
• Perform critical reviews of regulatory documents for writing standards, logic, content, presentation, clarity and accuracy of CMC information
• Interacts with Lonza Houston customers to provide regulatory support and to expand the ET business.
• Explores and evaluates new business opportunities.
• Conducts regulatory evaluations of new projects.
• Interacts with clients and potential clients to develop regulatory strategies, proposals and assist in writing regulatory submissions. Provides benefit/risk analysis for suggested strategies.
• Works with the Head of Houston RA to manage client regulatory submissions from initial client contact through drug product approval and post approval commitments.
• Coordinates the various projects in the local regulatory team; scientists, technicians and consultants.
• Maintains schedule of filings; monitors timelines and status for filings and completes routine filings in a timely manner.
• Performs and documents activities for submissions to regulatory agencies, registering facilities and preparing and filing the documents electronically in CTD format.
• Interacts with domestic and foreign regulatory agencies and clients in relation to facility improvements and client submissions.
• Ensures that all CMC documentation, which directly or indirectly supports the preparation of regulatory submissions, are prepared to meet requirements.
• Reviews, approves all documentation associated with manufacturing, validations, change control, deviations and SOPs.
Candidate Profile
BS-Chemistry or Biological Science
Additional Information:
Requisition ID: R6994
Job Location : US - Houston, TX
Industry Type: Pharma
Functional Area: Regulatory Affairs
End Date: 28th April, 2018
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