Regulatory Submissions Specialist

Detalles de la oferta

**Multiple Roles Jr/Sr/Manager****Mexico - 100% Remote Role.****Primary responsibilities will include the following**:- Work closely with submission managers to produce high quality submission assemblies(**eCTD/NeeS/Paper format**) utilizing submission-ready documents that adhere to internal and external electronic submission guidelines- Ensure submission assemblies meet the level of technical integrity required for health authority validation tools- Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies- Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions- Manage regional submissions and support global submissions as a Publisher- Manage and/or mentor junior team members- Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines.**Job Types**: Full-time, ContractPay: $25,000.00 - $60,000.00 per month**Experience**:- eCTD: 1 year (preferred)- Regulatory Affairs: 1 year (required)


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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