REGULATORY AFFAIRS MANAGER - ARGENTINA AND COLOMBIA

Colombia - Bogotamid

OtherRegulatory Affairs Manager

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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.