Regulatory Affairs Specialist - 858

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.

Responsibilities

1. Provide guidance and support about Mexican and Central America legislation.
2. Contribute to the regulatory activities performed, including pre-licensing activities, new registration (sites and medicinal products), and post-licensing regulatory submissions.
3. Contribute to the production of client administrative documents for regulatory submissions.
4. Compile regulatory dossiers in accordance with national requirements.
5. Manage and administer systems.
6. Document and track regulatory submissions and regulatory authority approvals.
7. Provide regulatory support to clients and associate companies.
8. Liaise with sponsor head-office and affiliate departments on regulatory issues.
9. Review packaging texts.
10. Review formats of Summary of Product Characteristics, Patient Information Leaflets, and labeling (e.g., QRD compliance check).
11. Contribute to data entry in PLG tools to enable measurements of KPI and metrics for regulatory services.

Education & Experience

1. Bachelor’s degree or higher in a Life Sciences related field; a Pharmacy degree is a plus.
2. 5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider.

Profile

Hard/Technical skills:

1. Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in LATAM.
2. Knowledge of MX and LATAM (Guatemala, Panama, Dominican Republic) regulations for pharmaceuticals (NCE, Biologicals, and Biotech), Medical Devices, Combination products.
3. Good understanding of data and document management systems and MS Office applications.
4. Experience with new registrations of drug products is preferable.
5. Excellent organizational and interpersonal skills.
6. Ability to work well within a team and autonomously.
7. Ability to prioritize different workloads and multi-task.
8. Ability to deliver on tight timelines.
9. Process-oriented with good attention to detail.