Regulatory Affairs Associate (FTC)

Novartis Farmacéutica; Midrand; On-site; ZAR 40 000 - 80 000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to contribute to product registration and compliance. In this pivotal role, you will ensure that all submissions meet local regulatory requirements while maintaining strong relationships with stakeholders. Your expertise in regulatory compliance and project management will be crucial as you navigate the complexities of product licensing and reporting. Join a forward-thinking team dedicated to improving patient outcomes and making a significant impact in the pharmaceutical industry. If you're passionate about regulatory affairs and want to be part of a collaborative environment, this opportunity is for you.

Qualifications

• 3-5 years of regulatory experience with eCTD submissions.
• Strong project management and operations execution skills.

Responsibilities

• Achieve optimal product registration and maintain product licenses.
• Ensure compliance with regulations and foster stakeholder relationships.

Skills

Analytical skills

Attention to detail

Project planning

Regulatory compliance

Education

BPharm Degree

Job description

- Contributes to and supports the development of submissions for product registration, progress reports, supplements, amendments, and periodic experience reports. Supports all registration activities within the Department to ensure compliance with local pharmaceutical regulatory requirements.

About the Role

Major accountabilities:

1. Achieve optimal product registration with commercially attractive labeling in accordance with the registration plan.
2. Maintain and secure product licenses, including CMC/CDS/safety updates, according to local regulations, laws, guidelines, company strategy, and global compliance.
3. Ensure 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.).
4. Foster and maintain good relationships with internal and external stakeholders.
5. Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

Registered with the SAPC. Minimum BPharm Degree.

Work Experience:

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

Skills:

• Analytical skills.
• Attention to detail.
• Project planning.
• Regulatory compliance.

Languages:

Please specify language requirements here.

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