11 oct
|
Thornton Tomasetti
|
Bogotá, D.C.
11 oct
Thornton Tomasetti
Bogotá, D.C.
Main Purpose of the Role
Manages teams within the Regulatory Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short‑term operational/tactical responsibilities.
Main Responsibilities
As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following:
- product plan development and implementation
- regulatory strategy
- risk management
- chemistry manufacturing control (CMC)
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions,
technical labeling, appropriate regulations and interpretations.
Qualification Education
Associates Degree (± 13 years)
Experience / Background
Minimum 7 years
The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Regulatory Operations
DIVISION: CRLB Core Lab
LOCATION: Colombia > Bogota : Building II
WORK SHIFT: Standard
TRAVEL: Yes, 15 % of the Time
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Not Applicable
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, general network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next‑generation diagnostics, life‑changing de
📌 REGULATORY AFFAIRS MANAGER (Bogotá, D.C.)
🏢 Thornton Tomasetti
📍 Bogotá, D.C.