BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Franklin Lakes, New Jersey
Job Description Summary
Leads & Executes the maintenance of BD regulatory files, directly or indirectly (BDX, third party) Leads and executes the development of tools/systems/SOP for ensuring efficient RA activities. Ensure training and maintenance. Collaborates with Regulatory Compliance to enable product approval through site registration/certification Leads & Executes Regulatory Intelligence.
Manage Regulatory Affairs ProjectsLeads & Executes the maintenance of BD regulatory files, directly or indirectly (BDX, third party) Leads and executes the development of tools/systems/SOP for ensuring efficient RA activities. Ensure training and maintenance. Collaborates with Regulatory Compliance to enable product approval through site registration/certification Leads & Executes Regulatory Intelligence. Manage Regulatory Affairs Projects.
Maintenance of RA files
After 1st product launch, receive BD regulatory files for maintenance.
For legacy products (after first launch), plans and executes the regional registrations upon business needs. Determine regulatory status in other countries and register as applicable.
Provides regulatory assessment on change request, approves relevant ECRO, updates files upon needs, and notifies authorities as applicable.
Manage authorities inquiries
2. Development of tools/systems/SOP
Proposes, captures solutions to improve efficiency of RA activities, taking into account RA needs
Leads and executes development of those solutions, either tools/systems/SOP
Trains associates on new/updates tools/systems/SOP
Maintains, and continuously improve tools/systems/SOP
Provides regulatory requirements to QS linked to site registration/certification
Assists QS during site registration/certification as needed
Represents RA function in different committee/projects to mitigate regulatory risks
4. Regulatory Intelligence
Watches relevant sources of regulatory requirements
Identifies applicable documents that required attention for assessment, provides strategic recommendations for active participation to new/revised draft requirements, for comments to draft requirements, or for implementation in Business
Communicates strategic recommendations and participates to decision about applicability, owner of actions, implementation plan
Executes decision as applicable, communicates and trains on regulatory requirements
5. Management of Regulatory Affairs Projects
Supports the identification of the objectives, team members, timelines, milestones
Leads the execution, executes, communicates, reports status
Identifies risks and proposes mitigation plan
BS in Life Sciences, Master's preferred
2-3 years of experience in Regulatory Affairs (Pharmaceutical Industry or Medical Devices Industry) or in other functions (QA/R&D) in Health Industry
Collaboration in or Preparation of regulatory applications
Fluent in English
Knowledge in global regulatory requirements for registration of drugs & medical devices, US/EU minimum
Ability to establish network
Abilities in written & oral communication
Desire and ability to work effectively and efficiently in team environment
Ability in organization, prioritization, problem solving, decision-making in best interest of business, time management, planning, execution in due time
Primary Work LocationUSA NJ - Franklin Lakes
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