Regulatory Affairs Specialist Job at Ambio Inc, Grovetown, GA

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  • Ambio Inc
  • Grovetown, GA

Job Description

Job Description

Job Description

Salary:

Primary Responsibilities:

 

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

Qualifications:

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

ADA-These Requirements are a Condition of Employment:

 

  • Must be able to push, pull, squat, stand and walk through-out the day.
  • Must be able to push, push or lift up to 20lbs.
  • Must be able to wear safety shoes & glasses through-out the day while in designated areas. (Provided by the company)
  • You must be cleared by a physician and able to wear a respirator throughout the day while in designated areas.
  • You must be able to work in a chemical environment.

Job Tags

Shift work,

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