Regulatory Affairs Manager (Pharma - Must have FDA Submission Experience)

Job title: Regulatory Affairs Manager (Pharma - Must have FDA Submission Experience)

Contract type

Location: New York

Discipline

Remote: Yes

Salary: $45/hour - $50/hour

Reference: 462902

Contact name: Leah Shirley-Seykoski

Job Description Regulatory Affairs Manager

$45/hour - $50/hour

Hours: 4pm - 12am EST/ 1pm - 9pm PST

Starts ASAP Through June 28th, 2024

Our client,an NYC interactive agency focusing within the pharmaceutical industry, is looking for a highly organized, obsessed with details, loves-to-follow-rules, Regulatory Manager. 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 Regulatory Manager will be an essential member of the team, collaborating with producers, writers and editors. The right candidate will have pharmaceutical marketing experience and familiarity with MLR submissions.

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 our clients 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

Requirements

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