Associate Director, Regulatory Affairs, AD Promo
Praxis Precision Medicines, Inc.
September 04, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Location: Remote possible; flexibility to travel as needed.
Primary Responsibilities:
- Own Regulatory Affairs review and approval of advertising and promotional materials across channels (HCP/DTC, digital/social, sales aids, speaker, congress, disease awareness).
- Ensure promotional communications are accurate, appropriately balanced, consistent with approved labeling, and compliant with applicable FDA regulations/guidance.
- Partner early with Commercial, Medical Affairs, and Legal to shape campaigns/claims and reduce late-stage revisions/approval delays.
- Own required FDA promotional submissions (Form FDA 2253) and lead OPDP interactions (responses to inquiries/enforcement communications).
- Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends; translate into actionable implications/recommendations.
- Build scalable review processes (review practices, compliant records/archiving, coordination with Regulatory Operations; use Veeva PromoMats and RIM).
- Serve as a trusted regulatory partner across teams (labeling, scientific exchange/medical education, market access, PAIE, launch readiness, and other complex communications).
Qualifications:
- Bachelor’s degree in a scientific/pharmacy/health-related or relevant discipline; PharmD/MS/PhD/MD/JD preferred.
- 8+ years pharmaceutical/biopharmaceutical experience; at least 5 years in regulatory advertising/promotion.
- Deep, current FDA knowledge for prescription drug advertising/promotion; strong regulatory judgment.
- Experience supporting product launches and PAIE strongly preferred; CNS/neurology/rare disease preferred.
- Demonstrated experience with Form FDA 2253, OPDP interactions, and review across HCP/DTC/digital/social channels.
- Self-directed, ownership mindset; comfort making well-reasoned decisions with limited precedent; Veeva PromoMats/RIM or comparable systems preferred.
Compensation & Benefits (if applicable): Annualized base salary $200,000–$221,000; 99% employer-paid medical/dental/vision premiums; life/AD&D/disability; 401(k) match up to 6% and long-term incentives/ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO/paid holidays/shutdowns.
Primary Responsibilities:
- Own Regulatory Affairs review and approval of advertising and promotional materials across channels (HCP/DTC, digital/social, sales aids, speaker, congress, disease awareness).
- Ensure promotional communications are accurate, appropriately balanced, consistent with approved labeling, and compliant with applicable FDA regulations/guidance.
- Partner early with Commercial, Medical Affairs, and Legal to shape campaigns/claims and reduce late-stage revisions/approval delays.
- Own required FDA promotional submissions (Form FDA 2253) and lead OPDP interactions (responses to inquiries/enforcement communications).
- Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends; translate into actionable implications/recommendations.
- Build scalable review processes (review practices, compliant records/archiving, coordination with Regulatory Operations; use Veeva PromoMats and RIM).
- Serve as a trusted regulatory partner across teams (labeling, scientific exchange/medical education, market access, PAIE, launch readiness, and other complex communications).
Qualifications:
- Bachelor’s degree in a scientific/pharmacy/health-related or relevant discipline; PharmD/MS/PhD/MD/JD preferred.
- 8+ years pharmaceutical/biopharmaceutical experience; at least 5 years in regulatory advertising/promotion.
- Deep, current FDA knowledge for prescription drug advertising/promotion; strong regulatory judgment.
- Experience supporting product launches and PAIE strongly preferred; CNS/neurology/rare disease preferred.
- Demonstrated experience with Form FDA 2253, OPDP interactions, and review across HCP/DTC/digital/social channels.
- Self-directed, ownership mindset; comfort making well-reasoned decisions with limited precedent; Veeva PromoMats/RIM or comparable systems preferred.
Compensation & Benefits (if applicable): Annualized base salary $200,000–$221,000; 99% employer-paid medical/dental/vision premiums; life/AD&D/disability; 401(k) match up to 6% and long-term incentives/ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO/paid holidays/shutdowns.