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Associate Director, Regulatory Affairs

Depomed, Inc.

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Location: Newark, CA Posted Date: 4/19/2013 Position Type: Job Code: C441C5E0079B Required Education: Bachelors Degree

Description

Title Associate Director, Regulatory Affairs
Department Regulatory Affairs
Description This position has been created to supervise the post approval commitments for Depomed's marketed products, from CMC-related changes, Phase IV commitments, and Advertising, Promotion, and Labeling. The candidate will be expected to provide expertise in post approval regulatory requirements into practical, workable plans. She/he will be called upon to assist in general regulatory affairs and regulatory compliance functions of the company as needed.
Requirements
  • Develop regulatory pathways to ensure successful regulatory submissions.
  • Prepare FDA meeting documents, minutes and follow up.
  • Manage multiple approved NDAs for their post approval-related changes and commitments.
  • Devise workable plans for execution of these requirements, as well as performing on cross-functional teams to ensure their timely and accurate completion.
  • Involved in the review and approval of advertising, promotional, and scientific messages for Depomed products.
  • Reviews technical reports and summary documents (clinical, pharmacology & toxicology, chemistry & manufacturing) for adherence to regulatory guidelines, strategies, and commitments.
  • Recommends regulatory policies to assure adherence to FDA requirements.

  • Contributes to the modification, development and implementation of company practices and policies for regulatory affairs.
  • Provides regulatory expertise and policy support for good pharmaceutical practices (GCPs, GMPs, and GLPs).
  • Review technical reports from development, manufacturing, and/or support functions for content.
  • Provide clear and continuous feedback to the multifunctional staff on the status of pending supplements.

    EDUCATION and EXPERIENCE:
  • Experience with both development and commercial phases of the product lifecycle preferred.
  • Excellent verbal and written communication skills
  • Excellent attention to detail
  • Strategic, independent thinker and problem-solver capable of identifying risks and risk mitigation strategies
  • Ability to lead interdisciplinary teams and motivate staff
  • Outstanding interpersonal and effective task planning / coordination skills.
  • Strong teamwork, negotiation and influencing skills
  • Strong skills in Microsoft Office products, as well as knowledge with publishing tools and electronic submissions with FDA.

    About Us Depomed employees are passionate about creating great. Since our founding in 1995, we’ve worked hard to create a specialty pharmaceutical company that provides meaningful healthcare products to patients. Our expertise and hard work has led to multiple FDA approvals and product commercialization, for example, of two marketed products, Gralise® (gabapentin) and Glumetza® (metformin HCl), which utilizes our proprietary polymer-based drug delivery technology, known as Acuform®, a product development pipeline having late-stage product opportunities, and the recent addition of Zipsor® (diclofenac) to our line of marketed commercial products.

    Requirements

    Pleas see Job Description.
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