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Regulatory Affairs Manager
2 weeks ago
Job Title
Regulatory Affairs Manager
About Abbott
Abbott is a global healthcare leader, 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 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 the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
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 reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
What You'll Do
Primary Objective:
Responsible for regulatory compliance and registration for Abbottproducts in Saudi according to SFDA regulations & Abbott internal processes.
Report regulation changes and new requirements to management in affiliate and regional team.
Responsibilities:
- Assess new oppurtunities from regulatory perspective.
- Support in localization projects from regulatory perspective.
- Responsible for obtaining and maintenance of appropriate license and registration for al EPD products.
- Represent the company during discussion with authority's assessment of product changes, to ensure compliance with regulatory requirements.
- Preparing Regulatory plans and ensuring their implementation to achieve longterm objectives for products that can be quantified in terms of sales, market share and profit contribution goals.
- Label update, work closely with different manufacturing sources, QA and label development department to get labels developed, approved and implemented as per the time frame agreed with the management.
- Work closely with the marketing department to review and approve the promotional materials per the agreed guidelines & within the required time
- Reviewing and approving regional promotional campaigns in terms of promotional literature, advertising, mailing, A/V support etc.
- Maintaining effective communication with the local agent and SFDA officials.
- Being familiar with company products & competitors and monitoring their marketing activities through region.
- Working closely with supply team to avoid out of stock suitation.
- Handle sample room as per local procedure.
Required Qualifications
- University Degree in Pharmacy.
- Minimum 7 years experience in a regulatory position in healthcare industry in Saudi
- 2 years in a mangerial role
- Fluent in Arabic & English
Preferred Qualifications
- Familiar with local market Landscape
- Integrity, proactive, selfmotivation, resultoriented, strong tolerance of pressure, a quick learner, willing to take challenge
- Excellent communication, negotiation and interpersonal skills
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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