Hikma Pharmaceuticals USA Inc.

  • Manager, Drug Regulatory Affairs Labeling

    Job Location US-OH-Columbus
    Posted Date 7 days ago(8/7/2018 11:54 AM)
    Job ID
    2018-4642
    Job Function
    Regulatory Affairs
    Shift
    1st
  • Overview

    Leads the Hikma Pharmaceutical's regulatory labeling group in preparing and filing new multi-source product labeling that meets regulatory and manufacturing standards, and ensures maintenance of lifecycle product labeling. Ensures consistency of labeling across product families and compliance with policies, procedures and applicable regulatory authorities. Works closely with Senior Management on all issues surrounding labeling filings in order to obtain approvals for new products as quickly as possible.  Ensures that regulatory labeling requirements for both development and lifecycle products are completed on time and in compliance with FDA, and any other country specific regulatory requirements. Responsible for regulatory review of advertising and promotional material, and preparation and filing of OPDP submissions.

    Responsibilities

    • With minimal supervision, plans, manages, and critically reviews all incoming labeling work among the team. Manages the planning, writing, and reviewing of all regulatory labeling submissions (SPL, draft and final printed labeling). Writes and reviews clear, concise and accurate responses to inquiries from the FDA resulting from their review of these submissions. Manages and provides oversight of drug listing activities and issue resolution. 
    • Coordinates and facilitates activities with other internal departments within West-Ward to establish local policies and procedures for all regulatory filings which include review, submission and approval for all ANDAs, NDAs, supplements, and Annual Reports sent to the FDA. Reviews and assesses the risk assessment of critical submissions, and develops risk mitigation plan in order to ensure an expedient FDA approval. Recognizes issues and potential barriers, defines problems, identifies underlying principles, reasons, or facts, determines appropriate solutions, and utilizes resources to drive improvements of medium to high complexity.
    • Evaluates performance, provides coaching, and ensures direct reports are developing appropriate skills to meet the needs of the business. Ensures right first time compliance with regulatory submissions made to the FDA and that internal policies and procedures, 21 CFR, FDA guidances, and other customer requirements are met.
    • Keeps current in the regulatory guidances, practices and technologies necessary for all regulatory labeling submissions as appropriate through training, seminars and investigating new technologies, and brings this information back to the relevant groups to effect change. Provides education and training on regulatory labeling strategies and compliance issues to other functions. Identifies, develops, and implements new ideas and process improvements in order to ensure filings are meeting the constantly changing FDA requirements/standards.
    • Responsible for critical review and approval of Advertising and Promotional materials, and preparation of OPDP submission.
    • Other duties as assigned.

    Qualifications

    • Bachelors, Masters, or advanced degree in a scientific discipline required.
    • Minimum of 5 years of increasingly responsible regulatory labeling experience in the pharmaceutical industry, as well as experience with review of OPDP materials and submissions.
    • Demonstrated experience communicating with the FDA and leading/motivating a team to meet regulatory deadlines.
    • Strong presentation skills, meeting facilitation skills, verbal and written communication skills.
    • Ability to influence others by presenting alternative options persuasively.
    • Negotiation skills with internal and external government agencies.
    • Strong project management skills with the ability to plan, organize, and multitask.
    • Effectively processes thoughts quickly and accurately from one project to another.
    • Creative problem solving and strategizing abilities especially as it pertains to the regulatory requirements for complex filings like combination products and transdermal.
    • Broad knowledge of regulatory affairs.

    WWHIGH

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