## [Regulatory Affairs Portfolio Manager](/req-10089433-regulatory-affairs-portfolio-manager "Regulatory Affairs Portfolio Manager")
Job ID REQ-10089433
Oct 06, 2026
LOC_ZA
### About the Role
Major accountabilities:
- Achieve the best product registration with commercially attractive labelling in accordance with registration plan
- Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance –
- Ensure compliance with DBE/MCA, relevant local regulations and laws for related CPO activities (RIM updates, RMP, product packaging material, promotional materials/activities, g etc.)
- Foster and maintain good relations with internal and external stakeholders –
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Key performance indicators:
- Manage assigned product portfolios across multiple therapeutic areas.
- Develop and execute regulatory plans for new registrations, variations, renewals, safety updates, and dossier maintenance activities.
- Support accelerated approvals, line extensions, new indications, and product launches.
- Maintain current product licenses and ensure alignment with global regulatory strategy.
Minimum Requirements:
Work Experience:
- Manage complex product portfolios and regulatory work plans.
- Prioritize submissions, coordinate resources, and track milestones.
- Lead follow-up activities for approvals, health authority feedback, and implementation actions.
- Support business continuity through handovers, portfolio planning, and workload management.
- Partner with Medical, Quality, Supply Chain, Pharmacovigilance, Commercial, Global Regulatory Affairs, manufacturing sites, and external service providers (Cross Cultural Experience).
- Build and maintain effective relationships with health authorities and industry stakeholders.
- Provide regulatory guidance and influence cross-functional decision making.
Skills:
- Strong regulatory knowledge of South African pharmaceutical legislation and SAHPRA processes.
- Effective project management and prioritization skills.
- Attention to detail and dossier quality.
- Strong stakeholder management and communication capabilities.
- Ability to manage multiple submissions and products simultaneously.
- Regulatory systems knowledge (e.g., Regulatory Information Management systems, eCTD processes, regulatory databases).
- Cross-functional collaboration and compliance mindset.
Languages:
• English.
Education & Qualification
• B.Pharm. Registration with SAPC.
• Regulatory Experience: 3-5 years.
### Role Requirements
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture")
**Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally.
[Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf)
Division DIV_GD
Business Unit Development
Location LOC_ZA
Site Midrand
Company / Legal Entity ZA01 (FCRS = ZA001) Novartis SA (Pty) Ltd.
Functional Area FCT_RD
Job Type Full time
Employment Type Regular
Shift Work No
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Job ID REQ-10089433
### Regulatory Affairs Portfolio Manager
[Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Midrand/Regulatory-Affairs-Portfolio-Manager_REQ-10089433 "Apply to Job")