Regulatory Affairs Associate II

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Job DetailsJob Location Corporate Headquarters - North Augusta, SCEducation Level 4 Year Degree

REGULATORY AFFAIRS ASSOCIATE II

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Specific Duties and Responsibilities:

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• Assist in the management of project timelines and provides operational regulatory support to project teams and Senior Management.
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• Keep a track on the project timeline using the Gantt Charts, Spreadsheets & tools for project management
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• Performs project evaluation and mitigation for ongoing and future projects.
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• Identify the need for resources and communicate to the management.
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• Review and prepare reports required by federal agencies, other regulatory agents and customers.
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• Assist in the preparation of the site for customer and agency inspections, specifically for regulatory affairs.
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• Maintain document management systems, and data for company products (drug substance and drug product).
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• Preparing Records and Reports for the submissions and keeping track of the progress.
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• Facilitating necessary document retrieval from different departments and other manufacturing site.
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• Assist in preparing responses for customer and FDA deficiencies.
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• Evaluate the Process/Specification changes and its impact on the existing regulatory submissions.
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• Assist in notifying the customer regarding any regulatory dossier changes that might have an impact on their product quality.
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• Stay updated with new guidance documents evaluate its impact on the pre-existing and forthcoming projects.
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• Oversee the efficient implementation of quality standards, programs and processes to improve operational efficiencies and reduce/eliminate production waste Identify potential issues and facilitate management decision making.
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• Other responsibilities as assigned
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Qualifications, Skills and Knowledge requirements:

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• Minimum BS/BA degree in a chemistry or life science; RAC and/or graduate level courses in regulatory affairs desired. 
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• Minimum 2 year of relevant experience is required, ideally with experience the in the biotechnology or pharmaceutical industry
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• Familiarity with regulatory requirements for development of drug and biological products, including FDA and EMEA regulations and guidance’s and ICH and USP guidelines
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• Demonstrated ability to coordinate and work effectively with cross-functional teams.
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• Oversee all project activities on a day-to-day basis to ensure on-time completion of planned tasks.
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• Communicate and monitor the project functional tasks for operation team, research and development, sales and marketing.
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• Excellent verbal, written, and interpersonal communication skills.
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• Strong attention to detail.
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• Good organizational and time management skills; ability to work on multiple projects and adhere to timelines.
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• Willing to advance knowledge of regulatory practice through classes, certifications, webinars, etc.
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• Ability to shift priorities according to changes in department/facility needs and be open to different ideas and approaches.
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• Highly motivated, self-empowered, responsible, takes initiative, apply innovative solutions to solve problems.
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• Technical expertise with Windows, MS Office (Outlook, Word, Excel, Project, PowerPoint), Adobe Acrobat software systems, and experience working in an electronic document management system.
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• Must be able to push, pull, squat, stand and walk through-out the day
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• Must be able to lift up to 20lbs
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• Must be able to wear a respirator off and on throughout the day in designated areas.
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• Must be able to work in a chemical environment.
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