Expires soon Johnson And Johnson

Regulatory Affairs Associate (Junior)

  • Mexico City (Cuauhtémoc)
  • Legal

Job description

Job Description

Requisition ID: 1905714801W


Duties & Responsibilities:

1. Prepares required local submissions with a certain degree of supervision.
2. Follow up on mandatory requirements for registration: local certifications, importation of samples where needed and local testing, etc.
3. Compiles, prepares and submits regulatory documents and technical files to MoH to obtain approvals for new product registration, renewals & changes.
4. Updates Registered Codes Database, Labeling Database, Scanned Registers and other Regional tools as per approvals received.
5. May request documentation from OCs to prepare registration dossiers.
6. Reviews market licenses and labeling to input RA Sr Specialist/RA Manager to set up product codes status.
7. Active participation and timely delivery results in RA items to achieve common goals or attend common strategies.
8. Represents the RA team in multifunctional projects/meetings.
9. Ensures compliance with local MOH regulatory requirements.
10. Scans the external environment.
11. Supports SR. Specialist & Regional RA team when needed or required.
12. Prepares and approves labeling content.
13. Supervises the work of translation and dossier contractor with the help of Sr. Specialist.
14. Regulatory review of advertising materials.
15. Interacts with regulatory service providers.
16. Identifies and proposes local process improvements.
17. RA approval of supplies needed for supply chain processes (IFUs, local labels,etc).
18. Ensures compliance with local MOH regulatory requirements as well as CMS and J&J Corporate policies.
19. May identify and communicate new regulatory / legal requirements.
20. Product responsible person in countries where required.

Desired profile

Qualifications
Qualifications:

- Bachelor´s degree in Chemical/Pharmaceutical/Medical Sciences or Biomedical Engineer.
- Years of Experience: 2-3 years of experience.
- Required knowledge: Regulatory Environment.
- Required Experience: Desirable experience in Medical Devices, Pharma background is acceptable.
- Advanced English
- Location: Mexico City

Primary Location
Mexico-Distrito Federal-Mexico City-
Organization
Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function
Regulatory Affairs
Requisition ID
1905714801W

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