Empleos de productlife group

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

Responsibilities
Provide guidance and support about Mexican and Central America legislation
Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
Contribute to the production of client administrative documents to be included in regulatory submissions
Compile regulatory dossiers in accordance with national requirements.
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval.
Provide regulatory support to clients and associate companies
Liaise with sponsor head-office and affiliate departments on regulatory issues.
Provide review of packaging texts.
Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services
Education & Experience
Bachelor’s degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Profile

Hard/Technical skills:
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in LATAM
Knowledge of MX and LATAM (Guatemala, Panama, Dominican Republic) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
Good understanding of data and document management systems, MS Office applications
New registrations of drug products is preferable.

Soft skills:
Excellent organizational and interpersonal skills
Excellent communication skills
Ability to work well within a team and autonomously
Ability to prioritize different workloads/multi-task
Ability to deliver on tight timelines
Process orientated with good attention to detail
Solution driven
Fluency in Spanish and English