Senior Manager US Regulatory Affairs
BayerUpdate time: August 13,2020
Job Description

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Senior Manager Regulatory Affairs, are to:

 

  • Contribute to the development and implementation of product regulatory strategies for assigned monograph and NDA UR products in the US, enabling products to get to market as quickly as possible;
  • Participate in cross-functional teams and lead and/or participate in regulatory project teams supporting NPD for assigned UR products;
  • Participate in cross-functional teams working on developing product claims for labeling and promotion as well as commercialization of new UR products. Review for approval the assigned product consumer advertising (print/audio/video/electronic media) and product labeling;
  • Support maintenance and compliance activities of assigned marketed monograph and New Drug Application (NDA) products. These activities can include change controls, NDA Annual Reports and Periodic Adverse Drug Experience Report (PADER) / Periodic Benefit Risk Evaluation Report (PBRER) Annual Reports;
  • Support NPD activities such as label development of proposed product using the conditions specified under the relevant UR drug monographs or NDA labeling;
  • Complete other assigned and special projects to support Regulatory Affairs functional goals;
  • Interact with FDA representatives on issues concerning assigned UR products as requested by senior management;
  • Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends.
     

 

WHO YOU ARE

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Advanced degree in life sciences with a minimum of four years OTC drug regulatory experience; or a Bachelor of science degree with a minimum of six years of OTC drug regulatory experience;
  • Working knowledge of the US drug regulations (specifically 21 CFR Chapter 1 Subchapter D -Drugs for Human Use);
  •  Proven ability to understand and analyze these regulations;
  • Ability to communicate effectively in English verbally and in writing;
  • Proficient in MS Office;
  • Ability to accommodate changes and communicate them effectively;
  • Successful track record in contributing to/managing cross functional
    teams;
  • Substantial experience with multitasking in a deadline controlled and highly regulated environment;
  • Business savy and commercial orientation with a strategic and results
    mindset.
     

Preferred Qualifications:

 

  • Significant and relevant regulatory hands-on experience in support of UR monograph and NDA drug products.
     

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