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The Difference of One

Staff Regulatory Affairs Specialist

Apply Now Job ID R-307766 Date posted 05/16/2018

Job Description Summary

Job Description

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

Staff Regulatory Affairs Specialist will work in BD Medical Pharmaceutical Systems supporting Pre Fillable Syringe (PFS) Business and more specifically our most strategic customers (Global & Staregic Accounts). This position will provide solutions adapted to the global regulatory needs of our pharmaceutical customers and regulatory authorities.

The core of this mission is to acquire & deploy advanced medical device & pharma regulatory knowledge in a Business-to-Business environment to the service of our pharma customers for their successful WW registration.

Responsibilities:

Global Account Core-Team RA Member: Pharmaceutical Systems handles today 4 Global Accounts which have a WW footprint and which represent the majority of our revenues

  • Develop a deep knowledge and understanding of assigned Global Account
  • Participate to a globally coordinated and fully integrated cross-functional approach to anticipating & meeting customer needs.
  • Go beyond the usual regulatory practices and develop fully customized and integrated regulatory solutions that provide value to customer.

US Strategic Account RA Member:

Develop an advanced knowledge and understanding of assigned Strategic

Account(s)

  • Be the RA Member of the cross-functional Team supporting this account
  • Manage RA knowledge & networking with customers according to their products, therapeutic classes, markets, marketing plans…
  • Provide regulatory advice all along customers’ products RA lifecycle.
  • Support strategic decisions entailing RA challenges at customers.

Prefillable Syringe (PFS) Therapeutic Segments RA Member

  • Develop and apply RA expertise in the regulatory environment of the project: identify applicable and to come regulatory requirements and educate the cross-functional team accordingly.
  • Define accordingly Regulatory Strategy & Regulatory Plan for each targeted region
  • Execute Regulatory Plan: Prepare appropriate regulatory files and Regulatory Master Documentation.

Experience:  

  • B.S. degree required with life science or engineering background preferred
  • 5 + years of experience in Regulatory Affairs from Pharmaceutical Industry, Medical Devices Industry, Biologic primarily in the area of regulatory affairs. 
  • Current knowledge of drug/biologics/device cGMPs is preferred. 
  • Drug/Biologic submission knowledge, including regulatory change management, is preferred.
  •  Combination Product regulation understanding is a plus. 
  • Customer facing experience.
  • Strong Leadership skills.

Skills:

  • Customer service oriented (internal & external customers)

  • Strong empowerment & accountability
  • Strong team spirit, rigorous, integrity mindset
  • Autonomy and initiative mindset
  • Ambassador of the Regulatory Affairs function
  • Networking oriented (internal & external network)
  • Proactive  strategy generation and deployment
  • Advanced sense of priorities
  • Strong verbal communication  
  • Self-motivated with ability to effectively multi-task under pressure with minimal supervision

Primary Work Location

USA NJ - Franklin Lakes

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