Regulatory Affairs Specialist
Há 2 dias
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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