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.

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