Senior Regulatory Affairs Specialist
SENIOR REGULATORY AFFAIRS SPECIALIST- PHARMACEUTICAL:
The Regulatory Affairs Specialist ensures the appropriate licensing, marketing and legal for pharmaceuticals, to control the safety and efficacy of products.
**This is a contract to hire position. Local candidates only please**
KEY DUTIES & RESPONSIBILITIES:
- Prepare and follow-up on relevant regulatory submissions meet appropriate standards and content requirements, including planning and implementation around emerging/changing regulatory requirements
- Assist with the preparation of regulatory documentation to facilitate the commercialization of new products in the US.
- Create and submit 510(k), technical files, ADNAs and NDAs other registration documentation
- Review labeling and promotional materials to ensure consistency with regulatory approvals
- Post market surveillance responsibilities for medical imaging products
- Liaison responsible for communication with FDA and other regulatory agencies
REQUIREMENTS:
- Bachelor's degree in Scientific Field
- Minimum of 5-7 years of Regulatory experience in pharmaceutical and/or medical device industry
- Experience with ANDA, NDA, and Submissions
- Experience with ECTD (electronic submission) software
- Proficient in researching and ability to work independently and well with others under pressure
- Experience working in a CMO environment a plus as well as commercialization
To apply, please send resume to rebecca.howe@srg-us.com
