Based in the European HQ in Belgium, the Regulatory Affairs Strategy Coordinator reports to the Associate Director, Global Strategy & Implementation, CSS and assists and supports the CSS Regulatory Affairs Global Strategic Implementation Department in the execution of regulatory activities and organizational tasks.
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
1. Assists with organizational tasks for the CSS Regulatory Affairs Global Strategic Implementation Department.
2. Prepares departmental meetings and documentation for audit sessions (logistics, formatting, meeting minutes).
3. Supports department PO's, managing regulatory fees (Ariba).
4. Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented.
5. Administers the updating of regulatory processes, work instructions, training materials, and filing registrations to support Regulatory Affairs quality systems documents (including but not limited to Change Orders on SOPs).
6. Helps coordinate the preparation, delivery, archiving, and tracking of regulatory activities.
7. Conducts the necessary submission package for Certificate of Free Sales.
8. Organizes partnerships with the manufacturer to research, gather, prepare, and archive regulatory information necessary for submissions/registrations.
9. Conducts searches of existing files for requested information.
10. Assists with the preparation of responses to regulatory agencies' questions and other correspondence.
11. Codes, retrieves, and reports on data from Regulatory Affairs and related databases tracker and system to ensure prompt and accurate access to company regulatory information.
12. Fulfills product distribution requests in accordance with Regulatory compliance status.
13. Conducts the execution of product labeling customization activities.
14. Assists in the development of best practices for Regulatory Affairs processes.
15. Provides solutions to a variety of problems of limited scope and complexity.
16. Responsible for communicating business-related issues or opportunities to the next management level.
17. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
18. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
19. Performs other duties assigned as needed.
Qualifications:
Experience and Education:
* 0-2 years of work experience in Regulatory Affairs or Quality preferred.
* University/Bachelor's Degree or Equivalent.
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