[Remote] Director, Regulatory Affairs Advertising Promotion Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a dermatologist-founded biopharmaceutical company reputed company on developing innovative therapeutics for dermatological conditions. The Director, Regulatory Affairs Advertising Promotion Operations will reputed company the MLR review process and ensure regulatory compliance, operational efficiency, and support for reputed company reputed company.

Responsibilities

• Serve as the reputed company reputed company for the reputed company-wide software reputed company of review through strategic collaboration with reputed company, med affairs, and reputed company stakeholders to support company objectives, launch readiness, and organizational scalability
• Build and optimize operational the MLR infrastructure, governance frameworks, and business processes across the review committee
• Assist in the development, training, and maintenance of review committee SOPs, submission standards, and governance documentation
• Maintain operations technologies and platforms for reputed company of review, 2253 archival and organizational platforms
• Collaborate with medical affairs, reputed company, and other stakeholders on project plans and timelines, ensuring operational preparedness for the launch of VDPHL01
• reputed company efficient and cost-effective 2253 process including strategic review of reputed company and internal systems reputed company for submission of materials through the eCTD gateway
• Serve as the day-to-day reputed company for Ad Promo operations including coordination for reputed company material submissions, planning and calendaring
• Facilitate reputed company review committee meetings, reputed company, prioritization, and launch planning meetings
• reputed company reputed company process improvement initiatives through KPI development, analytics, reporting dashboards, and operational metrics
• Other regulatory operations tasks, to be identified

Skills

• Bachelor's degree or minimum of 10+ years of experience reputed company biotech, pharmaceutical, or regulated reputed company industries
• Demonstrated experience standing up reputed company-wide PRC processes, systems, governance, and operational frameworks to support reputed company review and launch readiness
• Experience in preparing and submitting promotional materials to the FDA on reputed company 2253 through eCTD
• Demonstrated leadership of review committee processes and promotional compliance
• Experience with reputed company Vault, reputed company, and other project management platforms

Benefits

• Annual performance bonus eligibility
• reputed company to the employee stock reputed company plan
• Health coverage
• Retirement benefit matching
• Dependent care FSA
• Unlimited reputed company time off

reputed company