Associate Director, Regulatory Affairs — Promo (Remote)

Praxis Precision Medicines, Inc.; United States; Ibrido; USD 200.000 - 221.000; Tempo pieno

Descrizione del lavoro

Praxis Precision Medicines, Inc. seeks an Associate Director of Regulatory Affairs (Advertising & Promotion) to lead the regulatory review of promotional materials across channels.

This role will partner with Commercial, Medical Affairs, Legal, and Regulatory Strategy to build a rigorous promotional review process and ensure timely, compliant campaigns for CNS-focused therapies. Ideal candidates bring deep FDA knowledge, strong judgment, and the ability to operate with autonomy in a fast-moving

Competenze

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline; advanced degree preferred.

Mansioni

• Own regulatory review and approval of advertising and promotional materials across channels.
• Apply regulatory judgment to ensure communications are accurate, balanced, and compliant with FDA guidance.
• Partner with Commercial, Medical Affairs, and Legal to shape campaigns and reduce revision delays.
• Lead FDA promotional submissions (Form FDA 2253) and OPDP interactions.
• Monitor FDA guidance and translate regulatory trends into actionable recommendations.

Conoscenze

Regulatory judgment

Direct communication

Cross-functional partnership

Autonomy

Decision making

Formazione

Bachelor's degree in a scientific discipline

Advanced degree (PharmD/MS/PhD/MD/JD) preferred

Strumenti

Veeva PromoMats

RIM

Descrizione del lavoro

Associate Director, Regulatory Affairs, AD Promo

United States - Remote

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

The Assistant Director, Regulatory Affairs, Advertising & Promotion will be the regulatory lead for advertising and promotional activities at Praxis, helping us communicate about our medicines with accuracy, integrity, and urgency as we work to bring high-impact treatments to patients with CNS disorders.

You will own the regulatory review and approval of promotional materials and partner closely with Commercial, Medical Affairs, Legal, Regulatory Strategy, and Regulatory Operations to build an efficient, rigorous, and scalable promotional review capability. This is a highly visible role for someone who brings strong regulatory judgment, communicates directly, and is comfortable making thoughtful decisions in a fast-moving environment.

Success in this role requires more than knowing the regulations. You will anticipate issues, challenge assumptions, find compliant paths forward, and help teams solve problems early rather than simply identifying risk at the end of the process. You will operate with significant autonomy and accountability while building trusted partnerships across Praxis.

Primary Responsibilities

• Own Regulatory Affairs review and approval of advertising and promotional materials across channels, including HCP and DTC materials, digital and social media, sales aids, speaker materials, congress materials, and disease awareness campaigns.
• Apply strong regulatory judgment to ensure promotional communications are accurate, appropriately balanced, consistent with approved labeling, and compliant with applicable FDA regulations and guidance while helping teams identify practical paths forward.
• Partner early with Commercial, Medical Affairs, and Legal to shape campaigns and claims, provide clear and actionable guidance, and reduce unnecessary late-stage revisions or approval delays.
• Own required FDA promotional submissions, including Form FDA 2253 filings, and lead Regulatory Affairs interactions with the FDA Office of Prescription Drug Promotion (OPDP), including responses to inquiries or enforcement communications.
• Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends; translate what matters into clear implications and recommendations for Praxis teams.
• Build and continuously improve scalable advertising and promotion processes, including effective review practices, compliant records and archiving, coordination with Regulatory Operations, and use of systems such as Veeva PromoMats and RIM.
• Serve as a trusted regulatory partner across Praxis, including partnering with Regulatory Strategy on product labeling, Medical Affairs on scientific exchange and medical education, and cross-functional teams on market access, pre-approval information exchange (PAIE), launch readiness, and other complex communications.

Qualifications

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline; an advanced degree such as a PharmD, MS, PhD, MD, or JD is preferred.
• 8+ years of pharmaceutical or biopharmaceutical industry experience, including at least 5 years focused on regulatory advertising and promotion.
• Deep, current knowledge of FDA requirements and guidance governing prescription drug advertising and promotion, with the judgment to apply those requirements effectively in situations where the answer may not be black and white.
• Experience supporting product launches, including pre-approval promotional planning and PAIE activities, is strongly preferred; experience in CNS, neurology, or rare disease is also preferred.
• Demonstrated experience with Form FDA 2253 submissions, OPDP interactions, and review of promotional materials across HCP, DTC, digital, social, and other channels.
• A self-directed builder who takes ownership, moves with urgency, stays curious, and is comfortable making well-reasoned decisions with limited precedent; familiarity with Veeva PromoMats, RIM, or comparable systems is preferred.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

$200,000 - $221,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

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Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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