
CMC Regulatory Specialist
Há 13 horas
We are seeking a highly skilled Regulatory Affairs specialist to develop and execute strategies throughout the development process. This is a fixed-term position lasting 24 months, located in Sao Jose dos Campos, Brazil.
Main Responsibilities:- Develop regulatory strategies and submission packages for new products and marketed products through filing and post-approval.
- Collaborate with internal research and development teams to execute CMC regulatory strategies.
- Provide direction on regulatory requirements for long-term company-wide regulatory strategies.
- Bachelor's degree in a relevant health-related scientific discipline or an advanced degree in a related field.
- Minimum 2 years of experience authoring and compiling Module 3 CMC sections and pharmaceutical industry experience.
- Advanced English language skills, intermediate/advanced Spanish language skills, and knowledge/familiarity with Brazil and Mexico regulatory registration of drugs.
- Excellent verbal and written communication skills, ability to work effectively in a team-oriented environment.
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