Regulatory Affairs Associate

Regulatory Affairs Associate

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.

Job Title:

Regulatory Affairs Associate Duration: 3 Months+

Location:

Malvern, PA

Job Description:

• Review Change Control
• Compile and author Annual Reports
• Build submissions in eCTD software
• Update spreadsheets and Database as needed
• Additional duties as requested
• Support the Regulatory Affairs team in reviewing Change Controls, writing Annual Reports, updating spreadsheets and Databases as needed.

Qualification:

• 1-2 years Regulatory Affairs experience
• Experience with the use of spreadsheets, word-processing, and database application Software. Excel, Adobe, Word
• Bachelor's degree preferred.