Medical Management

Ferreira Talita, MBA

Brazil – São Paulo

https://br.linkedin.com/in/talitaferreira

e-mail: ******.********.**@*****.*** Cel.: +55-11-996**-**** Objective: Seeking a Regulatory Affairs position in the pharmaceutical industry. SUMMARY

Pharmacist with more than 8 years experience in Regulatory Affairs in the pharmaceutical industry. Coordinated projects of generic, biosimilar and biological product submissions in Brazil combined with documents received from the FDA and EMA in-line with ANVISA’s requirements. Contributed with the approval and launch of more than 10 pharmaceutical products. Strong knowledge of International regulations. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level. Portuguese (native), English (fluent) and Spanish (advanced), improved in training, projects and meeting with countries from Latin America and Europe. Willing to move to another country and travel. PROFESSIONAL EXPERIENCE

January/2015 – December/2015 -NOVO NORDISK, Brazil Regulatory Affairs Specialist

• Successful track record in implementation of Regulatory Intelligence. Contributed more than 80% of regulatory view on company business, helping the launch of new products.

• Manages international submissions according to Health Authorities, answering queries and others requests.

• Provides support and technical assistance during preparation and review of regulatory documents for BLA (MAA, variations and renewals).

• Provides support and technical assistance during preparation and review of regulatory documents for Clinical Trial.

• Participate in cross-functional team activities from initial stages to securing government approvals and product launch.

• Monitors regulatory cycle times and variation for NDA/BLA as well as benchmark to Healthy Authority timelines.

• Prepares regulatory submissions according to country registration requirements to facilitate product approvals.

• Participation in meetings and training in other countries (LATAM and Europe). Interaction with stakeholders.

March/2014 – January/2015 – SANDOZ Pharmaceutical, Brazil Regulatory Affairs Senior

• Coordinates several international projects of medical devices, generic drugs and biosimilar. Due diligence of 22 projects submission. Contributed to the growth of 40% of marketed products.

• Implementation of Regulatory Intelligence, analyzing the information to determine impact on company business through Bulletin and monthly report.

• Manages Authorisation Applications, post-approval and renewals of Generic, Medical devices and Biosimilar.

• Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.

• Provides support and technical assistance during preparation and review of regulatory documents for Clinical Trial.

• Coordinates the company projects as well as Due Diligence, ensuring the project deadline is in compliance with all company procedures and policies.

• Coordinates and prepares the preparation of complex regulatory submission, including NDA and post- approval.

• Participation in meeting of entity groups and healthy authorities. Interaction with stakeholders. November/2010 – February/2014 – ACHÉ Pharmaceutical Industry, Brazil Regulatory Affairs Analyst

• Coordinates of local licenses required by Health Authority. Contributed to the approval of 12 licenses operation authorization, keeping approved the Licenses and Certifications.

• Coordinates projects of dietary supplements. Contributed to the approval of 2 products.

• Analyses of information in support of NDA annual reports and NDA periodic reports.

• Manages the coordination of regulatory ancillary documents and drug samples to support product registration and approval products in the Brazilian market.

• Prepares regulatory submissions of generic, brand drug and dietary supplements according to country registration requirements to facilitate product approvals (Authorisation Applications, Post-approval and Renewals).

• Writes and updated departmental Standard Operating Procedures (SOP).

• Participates in regulatory agency audits and supported to responses audit findings or other actions related to such audits, as needed.

May/2007 – November/2010 – VALEANT Pharmaceutical, Brazil Regulatory Affairs Analyst

• Participates in regulatory agency audits and responses to support audit findings or other actions related to such audits as needed. Contributed to approval of 3 Certificates of Good Manufacture Practice (GMP) audits, planning and implementing strategies to comply with the findings found in agency audits.

• Participates in training and education seminars as appropriate to learn international regulatory requirements.

• Plan, organize and submission of NDA and post-approval dossier, according to local requirements.

• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.

• Developed documentation to file for internal regulatory assessments for product design and labeling changes.

• Evaluates and send the pharmacovigilance reports.

• Participates in the final company document review and corrections (technical leaflets, surgical techniques, brochures, etc.), and ensures they are within the regulatory requirements of the various countries where the product is marketed.

June/2006 – May/2007 – QUALITY Pharmaceutical Consulting, Brazil Regulatory Affairs Intern

March/2005 – May/2006 – CARESSE Pharmaceutical Industry, Brazil Quality Control Analyst

EDUCATION

2014 – June/2016 Master of Business Administration (MBA), Management and Innovation in Health, Butantan Institute – São Paulo, Brazil

2015 Extension Course, People Management, FGV – São Paulo, Brazil 2014 Preclinical Development of Biological Products, CNPEM – Campinas, Brazil 2005 – 2009 BA, Pharmacy-Biochemistry, Paulista University (UNIP) – São Paulo, Brazil VOLUNTEERISM

• TakeAction Novo Nordisk, Project Coordinator – 2015

• Jesus é o caminho NGO, Project Coordinator – Since 2007

• Ver – Emilio Ribas Hospital, Animator – 2012 to 2014

Contact this candidate