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Regulatory Labeling and Promotion Lead

Date: Jul 12, 2019

Location: New York, NY, US, 10001

Company: Purdue Pharma L.P. & Affiliates

Working at our Company

Avrio Health L.P. is a privately held consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions. We have a strong portfolio of well-respected and proven effective brands, including Betadine®, Colace®, Senokot®, and SlowMag™ Mg. We put people at the heart of every decision we make and then leverage the best ideas from around the world to protect and promote health and wellbeing. Avrio Health aims to be a trusted partner in helping people live healthier lives.

Job Summary

Drive labeling and promotional (advertising) review processes for innovation and lifecycle management programs within the Avrio Health consumer product portfolio; this includes kicking off and driving labeling and promotional meetings in parallel with the overall development plan. Develop and manage technical support for annotated label texts and shepherd them through to completion (e.g. claim substantiation, medical/legal/ packaging statements).

Primary Responsibilities

  • Facilitate and drive end-to-end processes (from TPP to finished product) for labeling and advertising within the Avrio Health consumer product portfolio.
  • Initiate claim substantiation and work with subject matter experts to provide reliable support to be used in labeling, advertising and other promotional material.
  • Drive development and revision of annotated labeling text.
  • Monitor and track the status of labeling-related deliverables from the different functional areas, ongoing issues and activities.
  • Organize, compile, and maintain all labeling and advertising related documentation, ensure version control and compliance of filing and archiving requirements.  Prepare/submit Structured Product Labeling (SPL) to FDA, maintain relevant documents for Drug Listing, obtain/maintain National Drug Code (NDC) numbers, and prepare/submit mandatory dietary supplement notifications.
  • Schedule and lead labeling and advertising project team meetings; including preparing and managing the agenda, documenting key decisions and next steps and following-up on outstanding issues.
  • Coordinate with Packaging to develop and implement new/revised printed components.
  • Collaborate with internal and external functional areas and stakeholders to ensure good working relationships by delivering on commitments.
  • Obtain and maintain NDC numbers, drug listing activities and ensure that all are up-to-date and FDA compliant.
  • Keep current on regulatory intelligence relevant to job function.

Education and Experience

  • Bachelor’s Degree (BA/BS) in scientific discipline; Master’s Degree (MS/MA) – preferred
  • 3-5 years of Regulatory Affairs experience 6+ years within a consumer health company preferred

Necessary Knowledge, Skills, and Abilities

  • Some knowledge of OTC product regulations, ability to understand scientific topics i.e. FDA labeling regulations for OTC products, FDA Drug monographs, NDA process, Dietary Supplements and Medical Devices; knowledge of medical and regulatory terminology
  • Excellent written and communication skills with attention to detail, accuracy and clarity; Excellent proofreading/editing skills
  • Self-motivated, flexible, ability to multitask and prioritize in a fast-paced environment; Ability to manage complex issues, simultaneously; Ability to work well under pressure and adapt to changing priorities; Strong organizational and time management skills
  • Good problem-solving skills, both from a technical and procedural perspective.
  • Effectiveness in working cross-functionally with stakeholders in the labeling and artwork process from content development through commercial supply
  • Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint, SharePoint
  • Understanding of database development and maintenance in a regulated environment
  • Familiarity with Quality compliant systems for advertising and promotion, labeling, regulatory submissions and change control management

Supervisory Responsibilities (if Applicable)

Additional Information

Nearest Major Market: Manhattan
Nearest Secondary Market: New York City

Job Segment: Regulatory Affairs, Developer, Law, Advertising, Database, Legal, Technology, Marketing

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