Regulatory Affairs Lead: Strategy & Operations

Abbott Laboratories; Bogotá ciudad; On-site; COP 9,000,000 - 15,000,000; Full time

Job summary

Abbott Laboratories seeks a Manager of Regulatory Affairs to lead teams in strategy implementation and oversight of product registrations. You will coordinate submissions, liaise with regulators, and ensure timely approvals across the product lifecycle.

The role requires a minimum of seven years in regulatory affairs with experience in CMC, regulatory strategy, and cross‑functional collaboration to align development with regulatory expectations.

Qualifications

• Minimum 7 years of experience in regulatory affairs.
• Experience directing product registration submissions and regulatory strategy.
• Experience coordinating with regulatory agencies and cross‑functional teams.

Responsibilities

• Oversee strategy implementation and operations for product registrations and regulatory submissions.
• Interact with regulatory agencies to expedite approvals.
• Serve as regulatory liaison throughout the product lifecycle.
• Advise development and marketing teams on regulatory requirements and labeling.

Skills

Regulatory leadership

Regulatory strategy

CMC

Education

Associates Degree (± years)

Job description

Abbott Laboratories seeks a Manager of Regulatory Affairs to lead teams in strategy implementation and oversight of product registrations. You will coordinate submissions, liaise with regulators, and ensure timely approvals across the product lifecycle.

The role requires a minimum of seven years in regulatory affairs with experience in CMC, regulatory strategy, and cross‑functional collaboration to align development with regulatory expectations.