Regulatory Affairs Senior Analyst

2 semanas atrás

São Paulo, Brasil Biogen Tempo inteiro

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 and experience with CTD format, including ANVISA´s queries raised during dossiers evaluation;
- Follow-up of processes in progress with ANVISA / responses to queries issued and monitor registered competitors and new products registration movements at other Sanitary Agencies (as FDA and EMA);
- Follow-up on new ANVISA Public Consults and New Resolutions and evaluate potential business impact; attendance in Pharma Chambers Association meetings to discuss new Sanitary Public Consults and Technical Resolutions;
- Promotional, Institutional and Scientific Material review and approval based on applied regulation (RDC 96.2008 and Interfarma Ethical Code) in Veeva system with robust previous experience;
**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;
- Knowledge on API legislation and Biosimilar regulations is a plus;
**Additional Information**

**Why Biogen?**

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

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