Regulatory Submissions Specialist (Pharma) - 24 Seven Talent : Job Details

Client Overview: Our client, a NYC interactive agency focusing within the Pharmaceutical industry, is looking for a highly organized, obsessed with details, loves-to-follow-rules, Regulatory Manager.

Role Overview: The Regulatory Manager has the all-important role of coordinating with internal and external client teams to prepare submissions of marketing materials for our pharmaceutical clients medical, legal and regulatory (MLR) review. The marketing materials consist of pharmaceutical Web sites, videos, printed materials and online media projects such as banner advertisements. The right candidate will have pharmaceutical marketing experience and familiarity with MLR submissions.

Regulatory Submissions Specialist Responsibilities:

• Assist in filling in knowledge gaps on FDA regulations for Advertising & Promotion
• Thoroughly understand the intricacies of each client s Medical Legal Review (MLR) process, including working knowledge on the client s internal tools/systems for uploading and routing projects for review.
• Own and be accountable for the full MLR submission process for an assigned portfolio of clients, ensuring compliance with clients submission protocols and FDA/OPDP regulations.
• Create and maintain brand process documents, (e.g., Job Starter forms, Request templates, etc) to streamline submission process and ensure team alignment around submission details
• Work in Adobe Acrobat and SnagIt to prepare, annotate (e.g., references, explanation of functionality, etc.) and submit completed project materials to aid in quick and concise MLR reviews.
• Negotiate and communicate effectively with internal project teams and clients MLR teams to ensure timely submission in order to meet target MLR review dates and subsequent approval deadlines.
• Ensure MLR and OPDP compliance by consistently identifying efficiencies, proactively anticipating MLR team concerns, facilitating problem-solving and contingency planning for the expedited approval of all projects.
• Work with department heads to modify internal SOPs as necessary to ensure proper adherence to and efficiencies with MLR submissions.
• Maintain an archiving system that tracks and records MLR reviews, internal SOPs and supporting references.
• Conduct internal training and information sessions that contribute to employees adherence to the clients policies, processes and standards for promotional development and promotional compliance.
• Mentor and develop more Junior Regulatory Leads, and supervise their work

Regulatory Submissions Specialist Qualifications:

• 4+ years regulatory compliance/submissions experience
• Undergraduate degree or similar certification
• Advanced knowledge of Adobe Acrobat and SnagIt
• Intermediate knowledge of FDA Regulations