Cmcd Latam Coordinator - Ciudad de México - Bayer

Bayer

Empresa verificada

Ciudad de México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

CMCD LATAM COORDINATOR
At Bayer, our aspiration is to become a more flexible and agile company. We seek out ways to Improve Health and Nutrition - our Teams are key players to enable Innovation.

Consumer Health's headquarters is in Basel, Switzerland, with over 10,000 people in more than 100 countries. Our division comprises 12 manufacturing sites and 4 research and development centers.

Our brands hold leading positions in key categories including Allergy + Cough & Cold, Dermatology, Digestive Health, Nutritionals, and Pain + Cardio.

Today, Consumer Health produces some of the world's leading OTC brands, many of which are household names - including Claritin, Afrin, Bepanthen, Canesten, Alka-Seltzer, Rennie, Iberogast, Elevit, Berocca, Redoxon, Supradyn, Aspirin and Aleve.

Consumer Health's purpose is to Empower the Transformation of Everyday Health for millions of people around the world.

Through our broad portfolio of leading and trusted brands, consumers can take charge of their health - to get well, be well, and stay well.

ARE YOU a passionate and committed Team Player?

CAN YOU thrive with Ambiguity?

DO YOU collaborate well across diverse teams and contribute to a more inclusive environment?

CAN YOU build strong relationships with stakeholders?

DO YOU possess lean, agile ways of thinking and a strong digital mindset?

If you answered YES, this Opportunity is for YOU

Our ultimate goal:
Health for all Hunger for none.

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.

General:

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)
34 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).
23 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.

Período de aplicación: