Regulatory Affairs Director Epd Latam

hace 3 semanas

Bogota, Colombia Abbott Laboratories A tiempo completo

**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.
- 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.
- 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**

This position works in the Established Pharmaceuticals Division. Established Pharmaceutical Division is specialized and focus in pharma products which are able to provide different health solutions to the biggest health issues around the emerging markets, including Latinamerica.

As the Regulatory Director LATAM, is responsible for leading the regulatory affairs EPD function across Latin America, as principal responsibilities, define Regulatory strategy for LATAM region and provide strategig leadership to EPD regulatory teams.

**What You’ll Do**

The position is responsible for leading the regulatory affairs EPD function across Latin America, as principal responsibilities:

- Define regulatory strategy for LATAM
- Obtain registrations, renewals, variations and authorization of new products needed for adequate commercialization of our products in LatAM.
- Establish and control Regulatory remediation plan
- Manage public relationship with Health Authorities in LATAM
- Provide Strategic Leadership to EPD Regulatory teams to develop and execute RA strategies to aligned with business plan of EPD

**Knowledge, Experience and Education**:

- Education: Bachelor's degree; Master Degree preferrable
- 10 years of significan experience with the industry-specific
- Other qualifications/certifications: Advanced degree in scientific discipline preferred,
- Fluency in Spanish and English both written and oral

**Major Accountabilities**:

- Ensure Regulation Requirements complying with each country where operate across the region
- Coordinate product Dossier preparation with Local RA Heads
- Elaborate RA compliance plans and execution
- Combine Knowledge of scientific, regulatory requirements to develop products to meet global, regional and local RA requirements
- Ensure audits from Sanitary agencies are properly conducted and supported
- Responsible to managing strategic partnership with Operations, QA, Commercial, Development ang Global, providing orientation and support.
- Elaborate strategic RA plans to speed up product registration
- Represent RA at Regional and Global Meetings
- Additional information:

- This position will be primay Leader for Regulatory Affairs EPD Latin America. In conjunction with LatAm I&D Director and GMs, coordinate RA strategy aligned with EPD strategy.
- Organization Structure and Functions:

- Total jobs reporting directly to the role: 14 Directly reports and 11 Indirect reports

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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