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Regulatory Affairs Junior Analyst
3 semanas atrás
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 Regulatory Affairs Junior Analyst is actively accountable in daily activities to ensure on time business support such as (but not limited to):
- Provide technical support with New Synthetic and New Biological Medicines dossiers based on local sanitary dispositions;
- Evaluate level of robustness on data provided by Global Regulatory team to identify lack of requested information;
- Attend Pharma Chambers Meetings as a Reg. Affairs representative of Biogen;
- Inform technical needs for registration renewals on due date and elaborate related dossiers;
- Prepare Post-registration/variation dossiers and work on related ANVISA´s queries discussing Agency needs with RA Members;
- Keep the area files organization and maintain related controlled systems updated;
- Work with Global Artwork Team to create/update all Packaging materials items;
- Support regulatory team to develop local Working Regulatory Practices and Workflows;
- Handle Labeling (artworks and leaflet texst) updated based on new versions of documents per product;
- Attend in Internal Conference Calls with our International Regulatory team;
- Follow-up on new ANVISA Public Consults and New Resolutions, evaluate and discuss with RA team members potential business impact elaborating an impact analysis, monitor Biogen competitor’s;
**Qualifications**:
- Bachelor in Pharmacy and Biochemistry;
- Fluency in English;
- Strong skills in Microsoft Office (Excel, Word, Power Point);
- Previous 2-3 years of experience in Regulatory Affairs is required;
- Experience with Promotional Material review is a plus;
Additional Information
If you want to grow as a professional in a fast paced environment and in a great team, **please apply**
At Biogen we encourage you to be YOU and diversity is more than welcome
