344615BR
May 24, 2022
Colombia

Job Description

21,000. That’s how many people Novartis hires globally every year. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?

The people we serve need you to achieve the extraordinary. That's why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.

For more information about Novartis access www.novartis.com

Your responsibilities:

Your responsibilities include, but are not limited to:
• Guarantee that all portfolio in the market is under regulatory compliance. Fluent and timely communication with internal and external stakeholders (eg, QA , commercial, medical , INVIMA among others).
• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
• Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
• Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
• Manages multiple, large and complex global regulatory submission projects. Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Guarantee the Accuracy of data entered into RA platforms and fulfill KPI's. Submissions and approvals accomplished according to the regulatory plan and timely reflected in D. bases. Fluent and timely communication with internal and external stakeholders of any relevant information about assigned projects and portfolio. Regulatory Intelligence reports.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• Fluent English level.
• 3-4 years of relevant experience as Regulatory Affairs Manager.
• A seasoned, experienced professional with a full understanding of Regulatory affairs area, requirements processes and procedures, with an ability to resolve a wide range of issues in creative ways.
• Ability to demonstrate good judgment in selecting methods and techniques for obtaining solutions.
• Ability to network with senior internal and external personnel in own area of expertise.
• Ability to work and lead (a cross-functional team) in a matrix environment.

You’ll receive:

Competitive salary, annual bonus, life insurance, home office policy, flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, Gympass, and virtual self-development tools.

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud 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!

Commitment to Diversity & Inclusion:

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

We are an equal opportunities employer and welcome applications from all suitably qualified persons.


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
Global Drug Development
REG AFFAIRS GDD
Colombia
Bogotá D.C
Research & Development
Full Time
Regular
No
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344615BR

Regulatory Affairs Manager

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