Regulatory Affairs Specialist

Há 6 dias

São Paulo, São Paulo, Brasil Bristol-Myers Squibb Tempo inteiro
Join Our Team as a Regulatory Affairs Specialist

Bristol-Myers Squibb is a leading pharmaceutical company that is committed to transforming patients' lives through innovative medicines. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Brazil.

About the Role

The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements and guidelines in Brazil. This includes planning, preparing, and submitting regulatory processes, as well as tracking and following up on approvals. The successful candidate will have excellent communication and organizational skills, with the ability to work effectively in a team environment.

Key Responsibilities
  • Plan, prepare, and submit regulatory processes, including non-asset specific processes, to ensure compliance with regulatory requirements.
  • Track and follow up on approvals, ensuring timely delivery of pre-filing requirements.
  • Prepare registration renewal, HMP, and regulatory low-mid complexity filings, with minimal supervision.
  • Assist in the preparation of major filings, such as BLA, NDA, LCM, and DDCM, under the guidance of a GRS Manager.
  • Provide comprehensive and timely responses to HA queries, as well as SME support for product divestitures or deletions.
  • Prepare and submit extemporaneous mandatory notifications, and follow up on derived actions until completion.
  • Maintain regulatory records fully accurate and updated in BMS databases.
  • Review and approve promotional materials, and update procedures, manuals, and work instructions of the area.
  • Provide regulatory assessment during investigations of raising unforeseen issues.
Requirements
  • Bachelor's degree in Pharmacy is required.
  • Experience in the regulatory area, with a focus on new and biological drugs.
  • Excellent communication and organizational skills, with the ability to work effectively in a team environment.
  • Fluent in Portuguese and English, both written and verbal.
What We Offer

Bristol-Myers Squibb offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment, where employees can thrive and reach their full potential.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application today.

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