Regulatory Affairs Labeling Associate Level I is needed to support Client business to prepare and review 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.
Some key traits, should have Pharmaceutical Experience, worked in control environment to follow process, quality focus. An effective communicator and can work independently and collaboratively with everyone, additionally, having Generic labeling experience is a plus.
Education
Bachelor's or Associates degree in a scientific or English discipline.
Experience
Bachelors degree plus a minimum of 1 -2 years in the pharmaceutical industry with 1 of those years working with labeling, conducting reviews or
Associates degree plus a minimum of 3-4 years pharmaceutical industry experience working with labeling, conducting reviews.
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Industries
IT Services and IT Consulting
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