Senior Program Director, Commercial Regulatory Affairs

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🔥 0 minutes ago

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Logo of DAWAR CONSULTING INC

DAWAR CONSULTING INC

51 - 200 employees

Founded 2009

⚕️ Healthcare Insurance

👥 HR Tech

☁️ SaaS

Healthcare Insurance • HR Tech • SaaS

DAWAR CONSULTING INC. is a trusted provider of workforce solutions and professional services tailored for the Medical Science industry. Specializing in Human Capital Management (HCM) and ITSM consulting, DAWAR offers expert implementation of SaaS and Cloud-based solutions from platforms like Workday and ServiceNow. Their comprehensive staffing services include global talent acquisition, recruitment process outsourcing, and staff augmentation, ensuring that they connect skilled professionals with career opportunities while enhancing organizational productivity and efficiency.

📋 Description

• Lead Promotional Review Committee (PRC) meetings • Review and approve promotional and marketing materials • Provide regulatory guidance on advertising and promotional claims • Partner with Marketing, Medical, Legal, and Compliance teams • Support FDA communications and Form 2253 submissions • Ensure compliance with FDA regulations and healthcare industry guidelines

🎯 Requirements

• Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred • 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry • Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance • Experience leading cross-functional teams and Promotional Review Committees (PRCs) • Excellent communication, stakeholder management, and project leadership skills.

🏖️ Benefits

• Medical • Dental • Vision • Paid Sick Leave • 401K

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