Senior Associate I

2 semanas atrás

Sao Paulo, Brasil Biogen Tempo inteiro

Company Description

At Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

**Job Description**:
Our Senior Associate I (Regulatory Affairs Senior Analyst) is actively accountable in daily activities to ensure on time business support such as (but not limited to):

- Elaboration of New Synthetic and New Biological medicines dossiers (new MAAs and lifecycle management) based on local sanitary dispositions;
- Handle ANVISA´s queries raised during dossiers evaluation;
- Follow-up of processes in progress with ANVISA / responses to queries issued;
- Follow-up on new ANVISA Public Consults and New Resolutions and evaluate potential business impact;
- Monitor registered competitors and new products registration movements at ANVISA;
- Attendance in Pharma Chambers Association meetings to discuss new Sanitary Public Consults and Technical Resolutions;
- Promotional Material review and approval;

**Qualifications**:

- Bachelor in Pharmacy and Biochemistry;
- Fluency in English;
- Strong skills in Microsoft Office (Excel, Word, Power Point);
- Previous 5 - 6 years of experience in Regulatory Affairs is required;
- Experience with Promotional Material review is required;
- Robust Knowledge of local sanitary dispositions for Synthetic Products is mandatory;
- Experience with IFA is mandatory;
- Knowledge on API legislation and Biosimilar regulations is a plus;
Additional Information

If you believe you are result oriented, team player, with strong interpersonal and communication skills, and want to join a fast paced environment, **please apply**

At Biogen we encourage you to be YOU and diversity is more than welcome

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