Regulatory Affairs Expert - Advertising & Promotion (m/w/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

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