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Associate, Regulatory Affairs - United States  

Company managed [?] Still accepting applications

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.  This person will also be responsible for the system management of the RA fields for the Global Trade Import process.

Major Responsibilities:  Managing various regulatory licensing activities for the Infection Prevention business unit of BD. The position is also responsible for managing and maintaining device/drug listings and registrations at the federal level for the US. 

Position Requirements: Excellent organizational and communications skills is a must.  This position also requires teamwork, problem-solving, ability to multi-task and motivate resources in the gathering of information required. Experience with electronic drug submissions and knowledge of Quality and Regulatory requirements, especially those with a drug focus would be very helpful.  This person must be able to work independently with minimal guidance.


Superior attention to detail and organizational abilities

Accuracy in preparation of documents for submissions

Comprehensive research abilities

Effective oral and written presentation and communication skills

Comprehensive coordination and compilation of documentation

Be able to execute defined projects with minimum management guidance

Project coordination and management abilities

Requirements

Minimum BA or BS required, preferably in a scientific or health related discipline 

Minimum of 2 years of experience in Regulatory Affairs and Quality Assurance with Pharma and/or Medical Device firms

Knowledge of healthcare-related regulatory bodies such as FDA, MHRA, ISO, Health Canada, TGA is a plus

Understanding of related disciplines in a FDA regulated environment, including cGMPs

Must have drug submission experience.

Skills

Windows based applications: MS Word, MS Excel, MS Power Point, and   Adobe Acrobat.

Familiar with the various FDA databases.

Primary Work Location

USA IL - Vernon Hills

Additional Locations

Work Shift