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Regulatory Affairs Expert - Advertising & Promotion (M/F/D)
Tasks:
Provide regulatory review of advertising and promotional materials for assigned products, prepare required submissions, and participate in promotional review committee meetings.
Serve as regulatory point of contact for marketing departments for designated products.
Support creation, updates, and implementation of product labeling, including:
Package inserts and structured product labeling (SPL)
Medication guides
Container labels
Core safety data sheets
Maintain regulatory archives of product labeling.
Contribute as regulatory representative to project teams for commercial products, including support of post-marketing commitments.
May provide regulatory input on ex-US sales, promotion, and labeling matters in coordination with licensees.
May participate in scientific sessions and conferences as needed for regulatory affairs support.
May deliver other post-marketing regulatory services as required within the scope of the engagement.
Qualification:
Bachelor’s degree in life sciences or related field required; advanced degree (Master’s or Ph.D.) preferred.
5+ years of relevant pharmaceutical regulatory affairs experience (or 2+ years with Ph.D.).
At least 3 years of recent experience in regulatory review of advertising and promotional materials.
Direct experience interfacing with the FDA Office of Prescription Drug Promotion (OPDP) preferred.
Proven expertise in creation and implementation of product labeling.
Pharmacy, medical, or medical-legal background strongly preferred.
Familiarity with neuroscience products desirable.
Proficiency in Microsoft Office Suite.
Ability to work independently while collaborating effectively with cross-functional teams.
Strong ethical standards, attention to detail, and capacity to manage complex regulatory deliverables.
Requirements:
Start: asap, latest mid September
Duration: 6 months
Capacity: ideally 5 days per week, minimum 3 days per week
Location: initial visit onsite in Maryland, US; mainly Remote
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