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The Difference of One

Manager, Regulatory Affairs

Apply Now Job ID R-308783 Date posted 05/17/2018

Job Description Summary

Job Description

Responsible for writing domestic drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's, INDs, NDA Supplements: Prior Approval Supplements (PAS), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).

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:

  • Orchestrate the format and information in the development of regulatory submissions including New Drug Application (NDA), ANDA's and INDs in accordance with the current FDA requirements.

  • Write domestic drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's, INDs, NDA Supplements: Prior Approval Supplements (PAS), Changes Being Effected (CBE), IND Amendments and Annual Reports (AR).

  • Write responses to regulatory authority deficiency questions regarding product information or issues and submit Amendments to NDA Supplements/INDs.

  • Ensure accuracy of Clinical documents in compliance with Clinical Trial regulations for submission to FDA for execution of Clinical Studies.

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

  • Coordinate preparation of meeting packages and materials for FDA meetings and interactions.

  • This position will support drug and device regulatory strategies through design control activities.

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

  • Develop and maintain standard operating procedures or local working practices ensuring regulatory compliance.

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

Major Responsibilities:  Managing various regulatory licensing activities for the Infection Prevention business unit of BD.

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.

Education:

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

Experience:  

  • Minimum of 3 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

Specialized Knowledge:

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

Familiar with the various FDA databases.

Skills:

  • 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

Primary Work Location

USA IL - Vernon Hills

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com