Regulatory Affairs Specialist Africa

At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon.

This role is part of Alcons 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 organizations overall compliance and continuous improvement in operations

WE ARE SEEKING :

Bachelors 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 conflictsand 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.

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Required Experience :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1