Regulatory Affairs Senior Specialist-GEM And Levant

About Abbott

Abbott is a global healthcare leader that is creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You will have access to :

• Career development with an international company where you can grow your dream career.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune.
• A company recognized as one of the best big companies to work for and the best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity - Regulatory Affairs Senior Specialist- GEM & Levant

This position works out of our UAE office in the Established Pharmaceutical division.

This is a fixed term contract role for 1 year.

About Established Pharmaceuticals—We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines covers multiple therapeutic areas, including gastroenterology, womens health, cardiometabolic, pain management/central nervous system, and respiratory.

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

What Youll 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 countrys needs.
• Develop and create new labelling printout according to countrys 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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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