Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our new Sandoz!
The role of the Regulatory Affairs Portfolio Manager co-ordinates and manages the product registration and the product life cycle maintenance activities including the compilation and submission of applications in eCTD to the ZA HA, while providing regulatory, scientific, medical, marketing, technical and public relations support and support all RA Initiatives where and when required.
- New Products Submissions for registration:
- Compilation and submission of new registration applications to ZA HA in accordance with HA and Sandoz requirements.
- Timeous registration of all products in accordance with ZA HA and Sandoz requirements.
- Product maintenance Regulatory Compliance:
- Compilation and submission of Quality and Safety variations to ZA HA in accordance with HA and Sandoz requirements.
- Timeous approval of all variations to minimise supply challenges and ensure product compliance.
- Special activities: Regulatory Intelligence
- Provide accurate information to satisfy the technical and information requirements of different departments internationally and locally, as well as other stakeholders timeously.
- Document and report on the relevant RA activities timeously.
- Provide and ensure a high level of service, both to our internal and external customers.
- Provide marketing support by review of promotional material and support to brand teams.
- Networks/ Liaison: Build and maintain good relationships within the local and global organization and key stakeholders, and to contribute to a positive company image.
- Corporate Governance: Take responsibility for corporate citizenship within the sphere of influence and control, and to adhere to the companys governance policies.
- Competitive market related salary
- Learning & development opportunities
- Substantial medical aid subsidy
- Group Life benefits, including dread disease cover
- Company paid medical aid gap cover
- Generous leave policy, including parental leave
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
Role Requirements
Education: Bachelor of Pharmacy
Languages: English
Experience: Minimum 2 years in Regulatory Affairs
Commitment To Diversity & Inclusion
Sandoz embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
The Companys Employment Equity Plan and Targets will be considered as part of the recruitment process
