Responsibilities

• OPDP Submission Responsibilities
• Prepare, coordinate, and execute submissions of prescription drug promotional materials to FDA OPDP, including materials submitted using Form FDA 2253.
• Ensure required promotional materials are submitted at the appropriate time of initial dissemination or publication, as applicable.
• Compile submission-ready packages and verify required components for
• - Form FDA 2253
• - Pre-submission packages for accelerated approval products
• Coordinate electronic submission activities and ensure packages meet applicable FDA technical requirements.
• Maintain accurate records of OPDP submissions, correspondence, submission dates, versions, and acknowledgments.
• Perform quality-control checks to ensure that submitted materials correspond to the final approved versions released for use.
• Partner with Regulatory Operations and other functions to troubleshoot submission issues and maintain compliant submission processes.

Requirements

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline required. Advanced degree (PharmD, PhD, MS, JD, or equivalent) may be preferred depending on level.
• - 5+ years of Pharmaceutical or biotechnology industry experience, preferably within Regulatory Affairs, Advertising & Promotion, Regulatory Operations, Medical/Legal/Regulatory review, or a related function.
• - Experience with FDA-regulated prescription drug promotional materials.
• - Experience preparing or managing OPDP submissions strongly preferred.
• - Familiarity with electronic regulatory submission processes and document-management or promotional-review systems.
• - Understanding of FDA regulations and guidance applicable to prescription drug advertising and promotion.
• - Knowledge of OPDP processes and Form FDA 2253 submissions.
• - Strong attention to detail and document/version-control discipline.
• - Ability to manage multiple materials and submission deadlines simultaneously.
• - Strong written and verbal communication skills.

Preferred

• Hands-on experience with promotional material review platforms and regulatory submission systems.
• Experience with Veeva PromoMats or similar systems.
• Familiarity with eCTD and electronic FDA submission processes.
• Experience supporting product launches, label updates, or high-volume promotional submission environments.
• Knowledge of FDA enforcement trends involving prescription drug promotion.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
• Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process