Regulatory Affairs Senior Specialist-GEM & Levant (Fixed term contract)

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

Required Qualifications:

Bachelor’s degree of Pharmacy

Year of experience: 2-5 years

Experience in Regulatory Affairs . Registration requirement knowledge, Communication skills and analytical mindset,

Arabic & English language

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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