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**Sr CMC Associatte
Job Opportunity at
Pharma Search Partners, Inc.
Posted on Jan 2
Nature and Scope
This position, reporting to the Regulatory Affairs CMC Manager, supports the activities of the Regulatory Affairs department with emphasis on CMC submission elements.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Prepare CMC elements for regulatory submissions (ANDAs/NDAs/INDs) and related maintenance documentation (amendments, supplements, annual reports, etc.) for the US, and other Regulatory Health Authorities within defined time schedule.
Propose regulatory strategies for commercial changes and R&D activities to Regulatory Management for confirmation.
Ensure regulatory submissions are prepared to meet US FDA standards and Regulatory Guidance Checklists.
Participate in meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to the filing, escalating to management when appropriate.
Review changes to manufacturing processes, laboratory methods, and specifications to ensure compliance with FDA guidelines and to maintain adequate control and flexibility for the life cycle management of the commercial product portfolio.
Review and approve SOPs, protocols, technical documents, labeling, and stability data and reports to ensure suitability for regulatory filing.
Perform any other tasks/duties as assigned by management.
Qualifications and Requirements
Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or other scientific field required.
Minimum of 5 years in the pharmaceutical industry required; preferably this experience will include 3 years of Regulatory Affairs experience with a focus on CMC activities. Knowledge of special requirements for sterile products is desirable.
Proficiency in Microsoft Office, electronic document management systems. Understanding of eCTD submission format required.
Strong knowledge and ability to apply FDA regulations and cGMP requirements.
Must be able to work independently with minimal supervision.
Excellent organizational, interpersonal and communication skills (oral and written)
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