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Regulatory Affairs Manager FDA Products

Regulatory Affairs Manager FDA Products

Job Description

Central Garden & Pet Company (NASDAQ:CENT) is a leading innovator, marketer and producer of quality branded products for the pet, lawn and garden supplies markets. We are seeking a Regulatory Affairs Manager FDA Products to work in our Phoenix, AZ office.

 

This position assures FDA and state government documentation complies with regulatory requirements for applicable products.

 

Please visit our website for additional information www.central.com

 

KEY RESPONSIBILITIES

 

  • Ensure compliance of current products by reviewing and approving labels, ads, websites and other promotional material; assist with adverse event reporting; ensure wholesale drug and other licenses are kept up-to-date; assist with implementation and compliance of the Food Safety Modernization Act; and, other duties as required/requested by the Senior Director, Regulatory Affairs.
  • Develop content and format for regulatory submissions, such as amendments or supplements, for existing NADAs (New Animal Drug Applications) and ANADAs (Abbreviated New Animal Drug Applications). Negotiate directly with regulatory authorities regarding such filings.
  • Assist in development of content and format for regulatory submissions to include state regulatory agencies for drugs, feeds, remedies, and other applicable products, as appropriate.
  • Maintain/support existing drug filings including annual DERs and required MCSR reports.
  • Review regulatory publications to keep apprised of new regulatory developments.

 

Job Requirements

EDUCATION/SKILLS/EXPERIENCE

 

  • Bachelors Degree or equivalent
  • Must have 3-6 years related regulatory experience and/or training, or a combination of education and experience
  • Must have ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Must have ability to read, analyze, and interpret complex documents
  • Must have ability to respond effectively to the most sensitive inquiries or complaints
  • Must have the ability to remain level-headed with a corporate goal orientation while prioritizing multiple projects, crisis management, and work effectively with regulators, customers and co-workers. 
  • Excellent oral and written communications skills required. Organization skills in prioritizing and managing multiple projects.
  • Strong attention to details.
  • Solid interpersonal skills – demonstrated ability to work with a variety of people.
  • Team player – able to coordinate effectively in a team-oriented environment.
  • Self-starter – takes initiative to solve problems and make decisions.

 

CENTRAL GARDEN & PET IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER OF FEMALES, MINORITIES, VETERANS, AND DISABLED

CENTRAL GARDEN & PET IS A VEVRAA FEDERAL CONTRACTOR

Job Snapshot

Employment Type Full-Time
Job Type Legal
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Consumer Products
Required Travel Not Specified
Job ID 2348
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Regulatory Affairs Manager FDA Products


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