Website Alcon – A Novartis Division
Alcon, A Division of Novartis, is the global leader in eye care. Our mission is to discover new ways to enhance sight and improve people's lives. We were founded in 1945 as a small ophthalmic shop in Fort Worth, Texas. Over the past 70 years, we have become the world’s leading eye care company t… read morehrough a combination of innovative research and development, strategic acquisitions, and partnerships with renowned third-party organizations. Today, we proudly reach more than 90 percent of the globe – operating in more than 75 countries, serving 180 markets and employing more than 24,000 people. Alcon House 65 Peter Place Extension 13 ZA- Bryanston, Gauteng 2021 South Africa
This role is part of Alcon’s Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Regulatory Affairs Specialist is primarily responsible for ensuring product compliance with regulations, and maintaining product registrations. You will build effective relationships with internal collaborators and regulatory authorities to support strategic decisions and compliance for the Africa Region while you are based in Midrand. Your daily responsibilities will include:
Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals
Oversee promotional material approval for Alcon portfolio, ensuring ethical conduct and compliance with laws, codes, and regulations
Develop regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
Support products in the medical device and/or pharmaceutical family, ensuring adherence to relevant regulations
Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
Meet individual job requirements and contribute to the organization’s overall compliance and continuous improvement in operations
WE ARE SEEKING:
Bachelor’s degree in health sciences
Minimum 3-5 years of experience in a international Pharma/Medical device company
Fluent English. Written and spoken.
Demonstrated ability to lead and work effectively with multiple stakeholders – internal and external and excellent communication Adherence to timelines for key regulatory submissions.
Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks
Strong writing and detail-oriented skills in the form of high-quality regulatory submission documents
Nice to have experience in Veeva, SAHPHRA submission platforms
Nice to have experience in Regulatory submissions in export markets
HOW YOU CAN THRIVE AT ALCON:
Comprehensive benefits package
Training and continuous development; Be part of a high performing ophthalmology company with a lot of opportunities to further develop your professional career.
International exposure
Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will supportto achieve goals and performance.
Apply via company website ( https://www.alcon.com/ ) or
.wd5.myworkdayjobs.com