Synectics
Location: Princeton,NJ, USA
Date: 2024-11-13T08:43:41Z
Job Description:
Description:
- Regulatory Affairs Labeling Associate Level - II is needed to support Client' business to prepare and review drug product regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices.
- Support labeling review process with a Quality Assurance and data integrity mindset. Apply team concept to get things done and work collaboratively with everyone with transparency.
- Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence during preparation and review.
- Utilizing technical skills for learning new features and /or applications software which can support preparation and review activities.
Qualifications:
- Bachelor's or Associate's degree in a scientific or English discipline.
- Bachelor's degree + a minimum of 1 -3 years in the pharmaceutical industry with 1 of those years working with labeling, conducting reviews; OR
- Associate's degree + a minimum of 3-5 years pharmaceutical industry experience working with labeling, conducting reviews.
- Pharmaceutical Experience, worked in control environment to follow process, quality focus.
- An effective communicator and can work independently and collaboratively with everyone
- Having generic labeling experience is a plus.