About this role
JOB DESCRIPTION: 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 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 15 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Not Applicable