349061BR
Jul 28, 2022
Brazil

Job Description

Thousands of patients! This position will impact Novartis products in Latin America and United States. You will be part of the ESO team, which is a multicultural team with high global exposure and also will have involvement with suppliers from all Americas and relevant stakeholders.
The ESO Regulatory CMC Consultant manages and facilitates ESO regulatory CMC related activities resulting from change projects (including transfers, divestment, pruning and due diligence activities) and remediation activities of the External Supply specific (global and local) products in order to ensure timely supply to the markets in compliance with up-to-date regulatory requirements.

For more information about Novartis access www.novartis.com.br and www.novartis.com.

Your responsibilities:

At Novartis we want everyone to be able to be their best version, both in the work environment and in their personal lives. Therefore, we are continually evolving our way of work.

This position is eligible for the hybrid working model (face-to-face and virtual). At Novartis, teams have the autonomy to decide the best flexible working format, balancing team collaboration, team impact on Novartis business, and employee well-being. Further details regarding working model will be explained throughout the selection process.

Your responsibilities include, but are not limited to:

• Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance.
• Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
• Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Proactively communicate CMC regulatory strategies, risks & key issues throughout the life cycle in a timely manner to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.
• Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
• Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Complete graduation
• At Least 2 years experience on regulatory/CMC
• Working knowledge on regulations and NDA and post -register submissions knowledge on US FDA and ANVISA regulations is highly preferred.
• Fluent in English and in Spanish.

You’ll receive:

Competitive salary, annual bonus, pension scheme, life insurance, 30 days annual leave, year-end recess, home office policy, flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, free parking lot (Santo Amaro and Cambe), Gympass, Space Energized for Life, gym (Santo Amaro) and virtual self-development tools.

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’reproud of this, we know there is so much more we could do to help improve and extend people’s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:https://talentnetwork.novartis.com/network and subscribe your CV in our talent pool here https://www.novartis.com.br/carreiras/buscar-vagas/detalhes-da-vaga/317…
Novartis Technical Operations
NTO QUALITY
Brazil
Sao Paulo - Matriz
Research & Development
Full Time
Regular
No
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349061BR

ESO REGULATORY CMC CONSULTANT - NTO - SÃO PAULO

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