REGIONAL MANAGER CENTER COORDINATOR
Descripción de la oferta de empleo
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.
.
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 environment Regional regulatory strategy is desired ⦁ Language capabilities.
proficient in English, Spanish, Portuguese is desired
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 08/11/2024
- 06/02/2025
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