Regulatory Affairs Specialist
Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
Provide promotional labeling and advertising review support to Regulatory Affairs Reviewers.
Pre-review of assigned promotional material in an electronic review system
Proofread final laser copy to ensure all Copy Review Committee (CRC) comments have be incorporated.
Final QC review and approval of promotional material and preparation of submissions to FDA for preclearance and initial use (Form FDA 2253)
Primary contact for marketing operations.
Maintain Regulatory Affairs Compliance of promotional material through tracking and monitoring.
Attend high priority Copy Review Committee meetings to assist Regulatory Affairs Reviewers.
Participate in proofreading of product labeling components, package inserts, brief summaries as required by requested deadlines
Bachelor Degree or 2-4 years pharmaceutical industry experience
Basic understanding of pharmaceutical advertising requirements.
Exceptional attention to detail is critical for this job.
Experienced with proofreading technical documents.
Excellent interpersonal skills. Accurate and concise oral communications and writing ability.
Excellent organizational and time management skills.
Ability to multitask and meet strict deadlines.
Must be able to innovate, analyze and solve problems.