Drug Regulatory Affairs Coordinator
hace 4 días
Major accountabilities:
- Define the registration plan, and perform product registration activities in accordance with registration and launch plan, & maintain product licenses throughout their life-cycle, in compliance with local regulation and global strategy
- Review new projects and define the plan and strategy for their submission and approval in collaboration with Global DRA and related CPO functions
- Achieve the best product registration times, in accordance with registration plan
- Maintain and secure product licenses in terms of CMC/Safety/Labeling/Other updates, according to local regulations/laws/guidelines, the company’s strategy and global compliance requirements
- Ensure compliance with the code of conduct, relevant regulations and laws for related CPO activities (reporting, pharmacovigilance, labeling, promotional materials/activities, etc.)
- Foster and maintain good relations with internal and external stakeholders
- Report technical complaints / adverse events / special case scenarios related to Novartis products within the required timelines, and contribute with their solution as required
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- Pharmacist
- Operational management and project execution management
- Cross-cultural experience
- Knowledge of national and international requirements and regulation for medicinal products
- English
You’ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Sandoz
**Division**
SANDOZ
**Business Unit**
Commercial OPS SIR SZ
**Country**
Costa Rica
**Work Location**
San José
**Company/Legal Entity**
NOV PHA Logistics PAN
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes
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