Associate Director US Regulatory Affairs

21 May, 2020

Jobs

Associate Director US Regulatory Affairs

Bayer
Whippany, NJ

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Associate Director, Upper Respiratory Regulatory Affairs, are to:

 

  • Develop, communicate, implement and defend aggressive regulatory strategies for potential NPD opportunities in the US, enabling products to get to market as quickly as possible;
  • Support NPD activities by:
    (i) providing regulatory support to NPD project teams;
    (ii) concept review and labeling development;
    (iii) providing guidance for the content of Common Technical Documents (eCTD) preapproval submissions;
  • Be responsible for Health Authority interactions on assigned NPD opportunities;
  • Provide cradle to grave support for product labeling and advertising for assigned currently marketed products;
  • Ensure regulatory compliance of existing NDA dossiers including NDA Annual Reports and Periodic Safety Reports for assigned products;
  • Be responsible for Health Authority interactions on assigned marketed products;
  • Proactively identify regulatory issues/risks and design/execute mitigation plans;
  • Maintain current knowledge of regulations and industry environment and provide guidance on potential and evolving trends;
  • Participate on industry trade association working groups as requested;
  • Create and manage strong network with key stakeholders such as marketing, legal and other scientific personnel that facilitates collaboration.

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 six years of regulatory experience supporting monograph drugs and OTC NDA’s or a Bachelor of Science degree with a minimum of eight years of regulatory experience supporting monograph drugs and OTC NDA’s;
  • 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;
  • Experience with multitasking in a deadline controlled and highly regulated environment;
  • Business savy and commercial orientation with a strategic a results mindset.

 

Preferred Qualifications:

 

  • A proven strong track record of day to day ownership for OTC NDA products;
  • Direct interaction with Health Authorities in support of an OTC NDA;
  • Experience in support of OTC upper respiratory products.

Learn more here

Job posted: 2020-05-21