14 ago
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Johnson & Johnson
|
Ciudad de México
14 ago
Johnson & Johnson
Ciudad de México
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 General 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 general 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
📌 Regional Manager Center Coordinator (Ciudad de México)
🏢 Johnson & Johnson
📍 Ciudad de México