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,