Regulatory Affairs Associate - Midrand at Alcon - A Novartis Division

In this role you will be responsible for the implementation and maintenance of the defined regulatory strategy, under limited supervision.

The daily role of Alcon’s Regulatory Affairs Specialist:

• Works in close collaboration with internal stakeholders and supports multiple projects
• Provides support as needed for non-project related "regulatory excellence" activities.
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
• Responds to regulatory requests from across the organization in a timely manner.
• Provides high quality regulatory support for assigned products/projects.
• Partners with internal stakeholders (e.g., regions) to align on regulatory strategy to achieve business objectives.
• Develops training programs for internal stakeholders, as needed.
• Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
• In the absence of the Responsible Pharmacist, you will be responsible to the Pharmacy Council for complying with all the provisions of the Pharmacy Act 53 of 1974 as set out in Regulation 28 of the regulations relating to the practice of Pharmacy and other legislation applicable to the purchasing, importation, sale, storage, and distribution of medicines and to Alcon Laboratories (SA) as manufacturing pharmacy.

Knowledge and Skills:  

• Demonstrated ability to coordinate and work effectively with multiple stakeholders.
• Minimum of 2 year experience in Regulatory Affairs. Experience with Pharma or Medical Devices
• Ensures timely, clear communications to internal stakeholders on project status and issues
• Serves as role model and embraces corporate Values and Behaviors
• Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
• Meets individual goals as defined in the annual objectives.
• Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
• Strong writing skills in the form of high quality regulatory submission documents

Education:  

• BPharm degree and registered with the SA Pharmacy Council, MS or PhD advantageous