Position Details
Regulatory Cmc Specialist Apply
Role : Regulatory CMC Specialist
Location : (Hybrid, Swiftwater, PA.)
Rate : 35-40$/Per Hr.
Rate : 35-40$/Per Hr.
Note : It's a W2 contract position, No C2C offered.
MUST HAVES:
1) Previous experience doing a lot of technical authoring of CMC documentation and Health Authority responses
2) Expertise with MS Word, Excel, MS Suite
3) Vault Rim system in a bonus, or system that houses quality docs and regulatory submission
REQUIREMENTS:
MUST HAVES:
1) Previous experience doing a lot of technical authoring of CMC documentation and Health Authority responses
2) Expertise with MS Word, Excel, MS Suite
3) Vault Rim system in a bonus, or system that houses quality docs and regulatory submission
REQUIREMENTS:
- 2+ years Regulatory Affairs work experience in Bioscience or Engineering background.
- Bachelors degree in pharma, bio or engineering. Master degree a plus
- Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines
- Ability to manage multiple priorities efficiently
- Experience working on Project teams
- Demonstrated knowledge of microbiology, immunology, virology or bacteriology
- Excellent skills in communication & writing
- Heavy email communication
- Team environment, will transversely be working with scientists, marketing, supply chain
- Candidate needs a sense of urgency but must have the ability to temper that as needed.
- Day in the life: Support manufacturing and supply, ensure regulatory requirements are met, update product dossier, technical authoring, look at technical docs and author regulatory change, interpret results.
