Julia Costa Email and Phone Number
Julia Costa work email
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Julia Costa personal email
✉juliascosta@gmail.com | 🌍 Eligible for Critical Skills Visa |☎ +55 (21) 99728-1209 Trilingual Professional (Portuguese, English & Spanish) holding a bachelor's BSc in Degree in Regulatory Affairs also an MBA in Total Quality Management and over 18 years of experience as Regulatory Affairs Manager and Quality Manager with a wealth of international experience and continuous improvement for well-known multinationals in Europe, the USA, and Brazil. Able to quickly adapt to new processes and procedures while under pressure, results-driven, agile mindset, and drive for continuous improvement. Open and competent in remote work scenarios and available for travelling and relocation.🚀 Career Highlights:✔Monitoring regulatory intelligence, acting proactively on identified changes to regulatory requirements and working on improvement opportunities for regulatory and quality processes, policies and systems.✔Development and implementation of regulatory strategies and initiatives on a portfolio level, working collaboratively at the global level with other leaders to align on priorities and support the achievement of the organisational goals by contributing to prioritisation to support the projects and initiatives on an as-needed basis.✔Providing leadership to a team of regulatory professionals, coaching, mentoring and leading the team members to ensure full understanding of internal procedures and drive effective integration of processes.Demonstrating agile mindset and drive for continuous improvement, outstanding analytical, staff leadership, problem-solving, and communication abilities.Areas of Interest/Expertise: Regulatory Strategy and Operational Knowledge | Quality Management | Project Management | Leadership Experience.I’m always interested in hearing from former colleagues, managers, or just interesting professionals, so feel free to contact me if you want to connect.
Fundação Butantan
View- Website:
- fundacaobutantan.org.br
- Employees:
- 1995
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Gerente De Assuntos RegulatóriosFundação ButantanSão Paulo, Brazil
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Regulatory Affairs LeaderRoche May 2017 - PresentRio De Janeiro, Rio De Janeiro• Manage regulatory products’ lifecycle in Brazil and LATAM markets (New Drug Application, post-approval changes submission, response to deficiency letters, regulatory commitments, annual reports).• Provide regulatory oversight for impact to change control, discrepancy management and inspection management systems.• Work collaboratively at the global level with other leaders to align priorities and support the achievement of the organisational goals by contributing to prioritisation to support the projects and initiatives on an as-needed basis. • Lead health authority interactions for assigned projects with an expanded scope, representing Technical Regulatory at multidisciplinary meetings with health authorities.• Support local and international regulatory audits.• Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assess risks, and develop contingency plans, including major, complex applications.• Develop effective regulatory strategies and policies by shaping the regulatory environment.• Collaborate and enable self-managed teams and promote a culture of continuous growth and learning by empowering teams to make their own decisions and enable action.• Interpret and apply global/regional CMC regulatory policies and requirements for assigned portfolios.• Work a robust understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of commercial manufacturing of pharmaceutical products, including technical and scientific knowledge of pharmaceutical drug manufacturing with technical writing skills. -
Regulatory Compliance SupervisorGsk Sep 2013 - May 2017Rio De Janeiro E Região, Brasil• Developed ideas, led/co-led complex projects across divisions, developed and managed plans to achieve objectives.• Ensured regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.• Provided regulatory oversight for impact to change control, discrepancy management and inspection management systems. Supported local and international regulatory audits.• Investigated opportunities for regulatory innovation / promoted the use of novel approaches within the project team to resolve issues and problems.• Developed effective relationships with local & global internal partners.• Served as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision.• Led the preparation of CMC information for submission to regulatory agencies, generated CMC strategies, assessed risks, and developed contingency plans, including major, complex applications.• Provided training-related activities {e.g. compliance-related HR policies) and individual development plans, and participated in cross-disciplinary forums & learning opportunities.• Created and modelled adherence to all behaviours & values, embraced and complied with Global Chemistry Manufacturing and Controls Principles of Integrity.• Acted as a technical and scientific resource within the workgroup and guided the completion of difficult and complex projects. -
Senior Regulatory Affairs AnalystMerck Group Jun 2012 - Aug 2013Rio De Janeiro E Região, Brasil• Prepared registration and post-registration dossiers for submission to Anvisa to support the sale of medicines in the Brazilian market.• Provided regulatory oversight for impact to change control, discrepancy management and inspection management systems.• Followed legislative framework of registration and post-approval changes on pharmaceutical products.• Reviewed editing country-specific claims for marketing support material.• Ensured the Regulatory Department SOPs are up to date.• Maintained the appropriate filing and storage of regulatory documentation and performed additional administrative tasks to support the wider team. -
Quality And Regulatory ManagerSilvestre Labs Jan 2005 - Jun 2012Rio De Janeiro E Região, Brasil• Elaborated plans and prepared regulatory submissions for specific target markets for new products and product changes and obtained re-registration approvals in advance of licence expirations to ensure no disruption in product availability.• Communication with Regulatory Authorities to ensure product approvals are achieved promptly.• Maintained registration information (licence numbers, expiration dates, regulatory logs for annual reports, filing/printing of regulatory submissions, correspondence etc.).• Provided regulatory support to currently marketed products as necessary, including input on change requests.• Obtained and maintained an understanding of global medical device regulations for specific jurisdictions as assigned, such as regulatory requirements following ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 and became proficient/knowledgeable in global medical device regulations.• Managed multiple projects simultaneously and provided regular reports to regulatory management and others as required.• Provided support assistance in procedure updates where required; circulation of change requests.• Supported local and international regulatory audits.• Maintained and organised appropriate regulatory records to demonstrate compliance with applicable regulations.
Julia Costa Skills
Julia Costa Education Details
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Postgraduate Degree In Regulatory Affairs (Nfq Level 9) -
Mba In Total Quality Management (Nfq Level 9) -
Postgraduate In Industrial Pharmaceutical Technology (Nfq Level 9) -
Bachelor'S Degree In Industrial Pharmacy (Nfq Level 7)
Frequently Asked Questions about Julia Costa
What company does Julia Costa work for?
Julia Costa works for Fundação Butantan
What is Julia Costa's role at the current company?
Julia Costa's current role is Gerente de assuntos regulatórios.
What is Julia Costa's email address?
Julia Costa's email address is ju****@****gsk.com
What schools did Julia Costa attend?
Julia Costa attended Ictq - Instituto De Pós-Graduação Para Farmacêuticos, Universidade Federal Fluminense, Ufrj - Universidade Federal Do Rio De Janeiro, Ufrj - Universidade Federal Do Rio De Janeiro.
What skills is Julia Costa known for?
Julia Costa has skills like Biotecnologia, Garantia De Qualidade, Pop, Auditoria Interna, Auditoria Externa, Gmp, Sistema De Qualidade, Microsoft Office, Microsoft Excel, Pharmaceutical Industry, Quality Assurance.
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