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Regulatory Affairs Specialist
Há 1 mês
Bristol Myers Squibb is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.
Key Responsibilities- Prepare and submit regulatory filings, including BLA, NDA, and LCM, to ANVISA and other regulatory authorities.
- Develop and maintain regulatory strategies and plans to ensure compliance with changing regulations.
- Collaborate with cross-functional teams to ensure regulatory requirements are met.
- Provide regulatory support and guidance to colleagues and stakeholders.
- Bachelor's degree in Pharmacy or related field.
- Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Fluent in English and Portuguese, both written and spoken.
- Strong knowledge of regulatory requirements and guidelines, including ANVISA and FDA regulations.
Bristol Myers Squibb offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
