LATAM Regulatory Submissions Lead

Adalvo; Portugal; Presencial; EUR 78 000 - 103 000; Tempo integral

Resumo da oferta

Adalvo is seeking a Regulatory Affairs Submissions Manager LATAM to lead planning, coordination, and timely delivery of regulatory submissions across Latin American markets. You will manage dossier gap assessments, country-specific adaptations, and ensure successful registrations from start to Marketing Authorisations.

The role involves devising submission strategies, coordinating document packages, and interacting with authorities and third parties to maintain regulatory compliance across LATAM

Qualificações

• 7+ years Regulatory Affairs experience.
• Proven LATAM regulatory submissions capability is mandatory.
• Spanish language: advanced level, both speaking and writing.
• English language: advanced level, both speaking and writing.

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 all 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

Regulatory submissions

LATAM regulations

Cross-functional teamwork

Project management

Spanish (advanced)

English (advanced)

MS Office

Ferramentas

MS Office

Descrição da oferta de emprego

Adalvo is seeking a Regulatory Affairs Submissions Manager LATAM to lead planning, coordination, and timely delivery of regulatory submissions across Latin American markets. You will manage dossier gap assessments, country-specific adaptations, and ensure successful registrations from start to Marketing Authorisations.

The role involves devising submission strategies, coordinating document packages, and interacting with authorities and third parties to maintain regulatory compliance across LATAM