Regulatory Affairs Senior Specialist Abbott Laboratories

As Regulatory Affairs Senior Specialist, you'll be responsible for preparation and submission of dossiers according to country specific requirements and regulations.

What you'll do-

Regulatory Affairs Coordination

• Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety updates, pricing, labelling and site transfers.
• Responsible for preparation and submission of dossiers according to country specific requirements and regulations.
• Provide regulatory support for tender business.
• Respond to agency questions and develops/coordinates appropriate responses.
• Initiate the pricing documents based on each country's needs.
• Develop and create new labelling printout according to country's regulations for our core products without any disruption of the existence of these products.
• Communicate the updated patient Information Leaflet.
• Review promotional materials and submit to the agency in countries where MOH approvals are required.
• Handle promotional material s submission in MOH UAE.
• Interaction with health authorities throughout the lifecycle of products.
• Provide guidance to peers and other external partners.
• Coordinate regulatory organization processes with different partners in different countries.
• Communicate efficiently with all business partners and employees
• Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.
• Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations and information.
• Re-challenge the HA and regulatory responsible on the variation s tools and laws