LATAM Regulatory Submissions Manager - Strategic Impact

Adalvo; Almada; Presencial; EUR 90 000 - 120 000; Tempo integral

Resumo da oferta

Adalvo is seeking a Regulatory Affairs Submissions Manager - LATAM to lead regulatory submissions across LATAM markets, coordinating strategies and ensuring timely marketing authorisations.

The role reports to Regulatory Affairs Director, LATAM; requires 7+ years experience, LATAM submissions capability, and fluent Spanish and English. Caparica, Portuguese Republic, PT.

You will work with cross-functional teams, manage dossiers, and liaise with authorities to maintain compliant processes.

Qualificações

• At least 7 years Regulatory Affairs experience.
• Proven LATAM regulatory submissions capability.
• Spanish language advanced, English advanced.
• Experience with cross-functional teams and timelines.

Responsabilidades

• Initiating, coordinating and supervising the registration of medicinal products in LATAM markets.
• Coordinate and follow up on regulatory due diligence activities with cross-functional teams, ensuring timely assessment of dossier gaps, country-specific requirements, regulatory risks and feasibility for LATAM markets.
• Devising submission strategy for each project and partner, in line with all applicable requirements, and assign due dates
• Directing and coordinating preparation of document packages for regulatory submissions, in line with LATAM regulations and /or local pharmaceutical laws depending on the submission type and market
• Ensuring that all responses to authorities' requests are complete and timely provided
• Communicate with third parties to expedite submissions and ensure regulatory compliance
• Ensure that the related administrative documents (CPPs, GMPs, Manufacturing agreements, legalization, apostille, samples dispatch etc.) are provided on time and that their submission/approval process does not delay the application
• Interact with the project and functional teams to ensure that data generated is appropriate and will be compiled and submitted in accordance with LATAM requirements.
• Provide support for samples preparation and dispatch, when necessary
• Inform the relevant functions on the status and progress of assigned projects to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur
• Documenting and tracking regulatory related processes within the organization
• Ensure that the internal trackers and databases are kept up-to-date

Conhecimentos

LATAM submissions

Spanish (advanced)

English (advanced)

Regulatory affairs

Project management

Descrição da oferta de emprego

Adalvo is seeking a Regulatory Affairs Submissions Manager - LATAM to lead regulatory submissions across LATAM markets, coordinating strategies and ensuring timely marketing authorisations.

The role reports to Regulatory Affairs Director, LATAM; requires 7+ years experience, LATAM submissions capability, and fluent Spanish and English. Caparica, Portuguese Republic, PT.

You will work with cross-functional teams, manage dossiers, and liaise with authorities to maintain compliant processes.