Regulatory Affairs Associate (Ftc)

Novartis Farmacéutica; Gauteng; On-site; ZAR 30 000 - 70 000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to contribute to product registration and compliance activities. This role involves collaborating with stakeholders to ensure optimal product registration and maintaining licenses in line with local regulations. The ideal candidate will have 3-5 years of regulatory experience, showcasing analytical skills and project planning abilities. Join a passionate team dedicated to making a difference in patients' lives and be part of a community that values collaboration and innovation.

Qualifications

• 3-5 years of regulatory experience, capable of creating and submitting eCTDs.
• Strong operations management and execution skills.

Responsibilities

• Support product registration and ensure compliance with local regulations.
• Maintain product licenses and report technical complaints swiftly.

Skills

Analytical Skills

Project Planning

Regulatory Compliance

Job description

About the Role

Major accountabilities :

1. Contribute to and support the development of submissions for product registration, progress reports, supplements, amendments, and periodic experience reports.
2. Support all registration activities within the Department to ensure compliance with local pharmaceutical regulatory requirements.

Responsibilities include:

• Achieving optimal product registration with commercially attractive labeling in accordance with the registration plan.
• Maintaining and securing product licenses, including CMC / CDS / safety updates, according to local regulations, laws, guidelines, company strategy, and global compliance.
• Ensuring compliance with Fuse, BeSure, the code of conduct, and relevant regulations and laws for related CPO activities (DRAGON updates, RMP, packing materials, promotional activities, drug safety reporting, etc.).
• Fostering and maintaining good relationships with internal and external stakeholders.
• Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

Qualifications:

• Regulatory experience of at least 3-5 years, with the ability to create and submit eCTDs.
• Functional breadth and cross-cultural experience.
• Operations management and execution skills.

Skills : Analytical skills, project planning, regulatory compliance.

Languages : Please specify language requirements here.

Why Novartis :

Helping people with disease and their families requires more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives.

Ready to create a brighter future together?

Learn more

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