HAVE YOU EVER DREAMT OF MAKING AN IMPACT ON THE WORLD?

How?

Become a Regulatory Affairs Specialist for our Established Pharmaceutical Division.

If you are inspired by our commitment to improving patient care, this role might well be what you have been looking for!

HOW WILL YOU MAKE A DIFFERENCE?

This role is responsible for:

• Lead the execution of New Product Introduction (NPI) Registration. Assure the registration of New Products.
• Maintain current and in compliance all Marketing Authorizations in Mexico
• Support with regulatory analysis/strategies for around 100 changes controls indicated by Operational or QA Teams.

Submit variations and renewals of the current Marketing Authorization.

Core Job Responsibilities:

• Regulatory strategies for registration of new products.
• Maintain the marketing authorization fulfilling with the authorized conditions to avoid quality issues or with the Health Authority.
• Participate in Pharmaceuticals Cameras to get regulatory compliance knowledge.
• Provide permanent pharmaceutical and regulatory consultancy for all matters that involve the company in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC), etc.
• Working closely with representatives in local team such as Operations, Quality, Supply, Pharmacovigilance, Legal, Importation, etc. in order to define and execute required RA activities to assure that our products are in accordance with Abbott’s internal Quality standards and international regulations, such as e.g ICH, GMP, EQD  etc.

CAN’T WAIT TO GET STARTED?

To be successful in this role, you will require the following qualifications:

• Pharmacist Bachelor’s Degree
• Experience required 3 years in Regulatory Affairs.
• Deep understanding of the LATAM regulatory environment and current legislations
• Good Manufacturing Practices
• Technical and fluent English
• Skills in solving problems and focused on results.