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/AIn 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