Regulatory Affairs Manager

1 week ago

Riyadh, Saudi Arabia Abbott Laboratories Full time

**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 long-term 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
- 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 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, self-motivation, result-oriented, 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. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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