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Sr Associate I, Regulatory Affairs São Paulo Brazil,  

Posted on : 25 April 2017

Project Description

External Posting TitleSr Associate I, Regulatory Affairs Job Description- Elaboration of New Synthetic and New Biological medicines dossiers based on local sanitary dispositions;- To align local technical needs with Global Regulatory technicians;- Handle ANVISA's queries raised during new products evaluation;- Prepare Registration renewal dossiers and inform technical needs on due date to International team;- Prepare Post registration/variation dossiers and handle ANVISA's queries related to these process;- Keep the control and renewal of Local Sanitary Licenses at District and Federal level as well as with Pharmaceutical Council on annual basis;- Assure organization of regulatory documents ( hard copy and in electronic format) for all products registered;- Follow-up of processes in progress with ANVISA / responses to queries issued;- In charge of labeling update process based on new versions of this document per product, received by Global Regulatory Labeling Group; - Active participation in Conference Calls with our International Regulatory team;- Support FMV in PSURs elaboration;- Integration and contact with our international technicians to resolve doubts about our sanitary requirements and requested information necessary to elaborate our local registration and answer Agency queries during dossiers analysis;- Regulatory Intelligence: Follow-up on new ANVISA Public Consults and New Resolutions; evaluate potential impact and create action plan with Area manager; - - Monitor of competitors new products registration;- Regulatory Governance: to maintain regulatory data control of all area spreadsheets/database related to our products and sanitary authorities;- Daily follow up of ANVISa's Publication on Brazilian Official Gazette and Agency website;- Control ANVISA's GMP Inspections in international manufacturing sites and related renewals based on local sanitary dispositions; - Good cross functional interaction providing technical regulatory support to all departments when needed;- Participate in Pharma Chambers Association meetings to discuss new Sanitary Public Consults and Technical Resolutions;New Products registration and variations dossiers elaborationRegistrations renewals, labeling update control and dossier elaborationGMP Inspections Control and dossier elaboration Biogen Licenses Control and renewals Regulatory database update Position reporting directly to Area Senior Regulatory Affairs and FV Manager under Medical Department umbrella; Support Regulatory Budget control/expenses;Mistakes in daily activities may generate serious impact to business due to exposition with Health Authorities, delay in registration/GMP renewals filing may direct impact MKT plans/and;Lack of outstanding interaction with ANVISA'top management as well as robust technical knowledge of local Regulations can delay product launches and patient access to the new medicinesDeliver results:Organization and detailed orientation;Focus on timelines;Work Cross Functionally;Strong sense of Regulatory Activities responsibility and direct impact to company business and image;Sense of priority;Good communication skills;Initiative and solutions/action plan skillsConstant Interest in acquiring new knowledgeDiscretion to handle confidential company data;Self-Control to work under pressure LocationSao Paulo, Brazil Job CategoryRegulatory Requisition Number31394BR QualificationsPrevious experience is required - more than 5-6 years;Fluency in English;Strong skills in TI programs: Excel, Word, Power Point, etc; EducationGraduation in Pharmacy and Biochemistry; About BiogenCorporate Overview Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options. Biogen was founded in 1978 and today serves patients in nearly 70 countries. A Fortune 500 company, Biogen in 2016 had revenues of $11.4 billion Global headquarters in Cambridge, MA, and international headquarters in Zug, Switzerland Our Science We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments. For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders. Biogen is revolutionizing biologics manufacturing, developing the industry s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines. Our Corporate Citizenship The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Please be advised that all legitimate correspondence from a Biogen employee will come from "" email accounts. Job Segment: Biochemistry, Biotech, Pharmaceutical, Biology, Science, Research


Sao Paulo, Brazil

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