Your Tasks and Responsibilities
New products (Business growth)
• Supports the CMC Manager with the authoring, reviewing, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Coordinates the timely request of information to the manufacturing sites, to review and/or update technical registration documents to be used in New Registrations.
Commercial products (Business continuity)
• Supports the CMC Manager with Site transfers (ST) projects and major API changes, by authoring, reviewing, and finalizing CMC documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Supports the CMC Manager with the coordination of some Manufacturing sites in regards to product lifecycle activities.
• Collaborates with the CMC Specialists for the timely and accurate assemblyof responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
• Responsible for the coordination/authoring for the timely delivery of Renewal packages for the LatAm region.
• Reviews CMC documents and reports created by the CMC Specialist for completeness, accuracy and for compliance with regulations, for Renewals and Variations.
• Prepare technical documents to support variation submissions, according to the regulatory assessment. This applies for variations where a higher level of technical expertise is required due to the complexity of the variations.
• Collaborates with the team by ensuring that all Data Bases used by the department are running correctly and are updated, to guarantee that the activities done are capture on time and properly.
• Communicates adequately and promptly with the CMC Manager to ensure compliance with the timeliness, or reviews possible solutions.
• Create, Compiles, reviews, approves and archives technical regulatory documents.
• Collaborates with other regulatory stakeholders (Dossier Owners, Local Regulatory Affairs, Global Regulatory Function), to ensure compliance of the technical documentation according to valid legislation.
• Ensures that the information originated by all CMC Mexico members is accurately stored in electronic System PharmDoss
Who you are
• Bachelor’s degree in Life Sciences (Pharmacy, Chemistry, Biologist)
• 3-4 years of experience in issuing CMC documentation for LatAm (Module 3), and at list 4 years of experience in the pharmaceutical industry (Knowledge of pharmaceutical development, testing or manufacturing processes.) (Preferable CMC experience with different LATAM legislations).
• Current experience with the regulation of almost all LatAm countries that will allow the authoring and coordination of the renewals and change controls. (Experience with Colombia, Peru, Brazil, Mexico and Central American countries is preferred).
• 2-3 years of experience in authoring Submission Ready Documents in electronic systems.
• Familiarization with the TRD and CTD nomenclature.
• Experience with the open parts of the Drug Master File.
• Ability/experience managing electronic document management system. (Preferable PharmDoss)
• Advanced English
Temporal contract, ending on December 31st, 2023.