Regional Manager Center Coordinator

hace 2 semanas

Ciudad de México Johnson & Johnson A tiempo completo

We are looking for the LATAM Regional Manager Center (RMC) Coordinator, in CDMX This rol is a Regulatory Affairs professional with cross-country project responsibility. The role purpose is to lead and handle efficient Regulatory Affairs life cycle activities within LATAM countries.Accountability: Leading a team of specialists and coordinating their efforts to achieve timely and effective regulatory submissions. Taking ownership of project outcomes and providing regular updates to the RMC Head.Key Responsibilities:- Lead the lifecycle regulatory activities for LATAM- Lead a team of regulatory specialists for the execution of submissions/approvals according to internal procedures and timelines- First point of contact for global / regional RA and collaboration with Global Labeling and Regional Strategic Implementation (RSI)- Plan and Monitor CMC variation / label change processes from global dispatch to submission- SPOC with global CMC for products/Therapeutic areas under their responsibility- Lead content deviation and support queries process- Performing and/or co-ordination of labeling Quality Check (QC)- in collaboration with other team members.- Training and supporting RA LOC, LA Regional Office and RMC team members for global processes under RMC scope (i.e. HA queries refresh)- Monitors reference country label approval and dispatch to specialist.- Support Products of Local Opportunity (POLOs) for specific cases.- Collaborates and demonstrate their Leadership according to internal Leadership Performance Standards- EffectivCommunication, leading by influence, clearly and persuasively. Intercultural social skills- Project Management to plan, implement, and lead all aspects of projects within established timelines e and budgets- Deep Quality Oversight: measurable by Audit results- Partnership within RMC and all customers- Innovation and Continuous Improvement: skills in problem-solving, critical thinking, and the ability to identify and implement process improvements- Operates in a complex, sophisticated, and constantly evolving environment.- Independence on decision-making regarding regional strategies**Qualifications**:- University degree or equivalent experience in Pharmaceutical Sciences- Approximately of 5 years of regulatory experience preferred in the region- Experience handling life cycle CMC variations- Experience of working in a virtual team and/or global organization.- Previous experience in RA role as Associate, Professional or similar role is of advantage.- Leadership: Supervisor experience- Able to build internal and external relationships- Experience in working with limited supervision and able to make independent decisions- Proactive teammate, able to take charge and follow-through. High degree of flexibility and ability to adapt to a changing regulatory environmentRegional regulatory strategy is desired- Language capabilities: proficient in English, Spanish, Portuguese is desired

  • Regional Manager Center Coordinator

    hace 2 semanas

    Ciudad de México, CDMX Johnson & Johnson A tiempo completo

    We are looking for the LATAM Regional Manager Center (RMC) Coordinator, in CDMX This rol is a Regulatory Affairs professional with cross-country project responsibility. The role purpose is to lead and handle efficient Regulatory Affairs life cycle activities within LATAM countries. Accountability: Leading a team of specialists and coordinating their efforts...

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