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Associate, Regulatory Affairs Vernon Hills United States,  

Becton Dickinson (company)


Posted on : 22 October 2017

Project Description

Job Description

Responsible for writing domestic drug regulatory submissions/licenses including NDA supplements; Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND Amendments and Regulatory authority responses.
Support writing of domestic drug regulatory submissions/licenses including NDAs, ANDAs, INDs.

Description: This position is responsible for managing various regulatory licensing activities for the Infection Prevention business unit of BD. Examples include, but are not limited to:

  • Write domestic drug regulatory submissions/licenses including NDA supplements; Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND Amendments and Regulatory authority responses.

  • Support writing of domestic drug regulatory submissions/licenses including NDAs, ANDAs, INDs.

  • Ensure timely and accurate submissions per business objectives and determine deliverables that are aligned with regulatory strategies.

  • This position will support drug and device regulatory strategies through participation in design control activities. Responsible for supporting projects through change control activities.

  • Coordinate activities with International team members in order to maintain effective collaboration as a Global RA team and to synchronize domestic and international submissions.

  • Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.

  • Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.

  • Provide guidance on development and review of labeling and promotional material in compliance with regulations.

  • This position will be responsible for managing and maintaining the device registrations and listings (FURLS) system for FDA cleared devices sold in the US.

  • This position will manage the establishment registrations and drug listings including the submission of SPL via ESG/CDER Direct for all drug labeling in the US.

  • This position will be the contact person for all inquiries as it pertains to Global Trade and customer inquiries.

Locations

Vernon Hills, Illinois

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