REGULATORY AFFAIRS MANAGER - ARGENTINA AND COLOMBIA

Colombia - Bogotamid

OtherRegulatory Affairs Manager

3 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). Ensures timely approval of new drugs,

Requirements Summary

Regulatory Operations DIVISION:CRLB Core Lab LOCATION:Colombia > Bogota : Building II ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Yes,

Technical Tools

OtherRegulatory Affairs Manager

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.

Responsibilities

~1 min read

→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.