Regulatory Affairs Specialist

Há 2 dias


São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiro
Job Title: Sr. Regulatory Affairs Analyst

About the Role:

We are seeking a highly skilled Sr. Regulatory Affairs Analyst to join our team at Bristol Myers Squibb. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines, as well as providing expert advice on regulatory matters.

Key Responsibilities:

  • Prepare and submit regulatory filings, including BLA, NDA, LCM, and DDCM, in a timely and accurate manner.
  • Develop and maintain regulatory strategies and plans to ensure compliance with changing regulatory requirements.
  • Provide regulatory support to cross-functional teams, including GRS, Labeling, and Marketing.
  • Collaborate with internal stakeholders to ensure regulatory compliance and provide expert advice on regulatory matters.
  • Stay up-to-date with regulatory developments and provide recommendations for process improvements.

Requirements:

  • Bachelor's degree in Pharmacy or related field.
  • Minimum 5 years of experience in regulatory affairs, with a focus on biological drugs.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Fluency in English and Portuguese.

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 that values and respects the contributions of all employees.

How to Apply:

If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information].



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