Regulatory Affairs Manager - Pharmaceuticals Division

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:

Managing all Regulatory & Scientific related issues in Saudi Arabia.

Responsibilities:

• Review and preparing biosimilar & other products registration files , and making sure all regulatory requirments are met.
• Working with Business Development and Marketing to set appropriate regulatory strategies on the short, medium and long term by adding new formulas and products to our portfolio.  
• Preparing Regulatory plans and ensuring their implementation to achieve long-term objectives for products that can be quantified in terms of sales, market share and profit contribution goals.
• As area New Product Introduction (NPI) coordinator, working with the marketing department for proper Business Case Forms preparation, posting on time and getting HQ NPP committee approval
• As area label coordinator, working 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
• As scientific area manager, working closely with the marketing department to review and approve the promotional materials per the agreed guidelines & within the required time- frame.
• 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 MOH officials across the region by field visits.
• Being familiar with company products & competitors and monitoring their marketing activities through region.
• Working closely with supply team to avoid out of stock suitation.
   

Required Qualifications

• University Degree in Pharmaceuticals.
• 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, self-motivation, result-oriented, strong tolerance of pressure, a quick learner, willing to take challenge
• Excellent communication, negotiation and interpersonal skills

Apply Now

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.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.