Regulatory Affairs Specialist Africa

Alcon Research; Gauteng; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A global leader in eye care is seeking a Regulatory Affairs Specialist based in Midrand, South Africa. The role involves ensuring product compliance with local and global regulations, coordinating submissions, and developing strategies for new products. Candidates should possess a Bachelor's degree in health sciences and have 3-5 years of experience in an international Pharma or Medical device company. A comprehensive benefits package and opportunities for professional growth are offered.

Benefits

Comprehensive benefits package

Training and continuous development

International exposure

Collaborative culture

Qualifications

• Minimum 3-5 years of experience in an international Pharma / Medical device company.
• Excellent communication and stakeholder engagement skills.
• Detail-oriented in regulatory document submissions.

Responsibilities

• Optimize outcomes and contribute to project goals through independent research.
• Coordinate product submissions and renewals with regulatory authorities.
• Develop regulatory strategies for product introductions and changes.

Skills

Fluent English

Strong writing skills

Ability to manage issues proactively

Education

Bachelors degree in health sciences

Tools

Veeva SAHPHRA submission platforms

Job description

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 you'll 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 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.

Responsibilities

• 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

Qualifications

• Bachelors degree in health sciences
• Minimum 3-5 years of experience in an 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

Benefits & Culture

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 support to achieve goals and performance.

Employment Type : Full-Time

Vacancy : 1