Associate Specialist Regulatory Affairs at MSD
Regulatory Affairs Specialist At MSD Egypt
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Obtain and maintain Products registration licenses in compliance with local regulations.
Work with Global Planning Regulatory Affairs team to advice on local regulatory requirements and give earlier guidance on products maintenance activities to ensure that local requirements are considered in the regional regulatory strategies.
Executes regulatory activities according to company plans.
Handles timely submission and follow-up of post-approval labeling and CMC variations.
Ensure that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place.
Ensures that regulatory databases and systems are kept updated and complete.
Ensures high quality labelling review and artwork management.
Ensures permanent compliance to local regulatory requirements and to company policies and procedures.
Ensures that local Quality activities are completed according to company Quality Systems and all legal requirements are met.
Keep monitoring any regulatory changes at health authorities that may impact the business and ensure effective communication to both business team and corporate Regulatory Affairs.
Effective communication and cross functional interaction with all involved stakeholders to ensure supply consistency.
Qualifications And Skills Required
Bachelor's Degree of Pharmacy or equivalent
Experience at least 2 years in Regulatory Affairs
High sense of customer orientation
High sense of collaboration
Advanced negotiation skills