Job Description

The Regulatory Affairs Manager is responsible for managing regulatory approval across the organization and outreach programs. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority products and programs.

• Direct the preparation and presentation of all necessary regulatory documentation across the organization, through active outreach to regional and global management of the RA team
• Ensure submission for product registrations are carried out in a timely manner in compliance with internal and external regulatory requirements.
• Responsible for department supervisory, issues management, establishing and maintaining regulatory networking internally and externally and preparing the company on planned/upcoming regulations to ensure business objectives are met.
• Develop regulatory-outreach plans working closely with other stakeholders (e.g., Regional/Global RA, Medical, Quality, Franchise, Research & Development) to ensure efficient approval of in-country products and programs
• Allocate RA personnel and resources to provide necessary documentation and support for high-priority compounds and products
• Provide necessary regulatory information, updates and documentation to organization, regional and corporate personnel, as necessary
• Ensure clear communication channels between stakeholders (e.g., Regional/Global RA, Medical, Quality, Franchise, Research & Development)
• Establishes and maintains reasonable and responsible regulatory climates locally though networking.
• Develops, retains, and improves technical knowledge and skills of local RA associates.
• Continuously acquires updated technical knowledge through training.
• Assume role of responsible person in Therapeutic Product Importer\xe2\x80\x99s and Wholesaler\xe2\x80\x99s licence.
• Other duties as and when assigned

• Degree in Engineering or Science or related scientific discipline, or equivalent

• Minimum 7 years\' experience in management of regulatory approval processes
• Clear and full understanding of relevant pharmaceutical and medical device regulation and approval processes
• Ability to engage regulators in trust-based scientific discourse
• Excellent oral and written communication skills
• Strong presentation skills
• Ability to lead and develop other scientific and professional reports
• Pharmacist License preferred

Alcon