Senior Regulatory Affairs Manager — Global Lifecycle Strategy

Abbott; Ciudad de México; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Abbott in Mexico City is seeking a Regulatory Affairs Senior Manager to oversee strategy and operations for product registrations, supplements, and periodic experience reports. You will lead cross-functional teams to ensure timely approvals and compliance throughout the product lifecycle.

The role requires 12+ years of RA experience, a Bachelor's degree (MBA preferred), and fluency in Spanish with strong English; you will interact with regulators, marketing and R&D to optimize regulatory

Qualifications

• Bachelor's Degree; MBA or equivalent postgraduate qualification preferred.
• 12+ years of progressive RA experience in Pharmaceutical industry; Proven leadership experience.
• Spanish: Native; English: Medium-High to Advanced level, capable of leading discussions and presentations in international environments.

Responsibilities

• Interacts with regulatory agencies to expedite approval of pending registrations.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in product plan development, regulatory strategy, risk management, and CMC.
• Ensures timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
• Advises development and/or marketing teams on manufacturing changes and regulatory interpretations.

Skills

RA leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's Degree

MBA or equivalent postgraduate qualification

Job description

Abbott in Mexico City is seeking a Regulatory Affairs Senior Manager to oversee strategy and operations for product registrations, supplements, and periodic experience reports. You will lead cross-functional teams to ensure timely approvals and compliance throughout the product lifecycle.

The role requires 12+ years of RA experience, a Bachelor's degree (MBA preferred), and fluency in Spanish with strong English; you will interact with regulators, marketing and R&D to optimize regulatory