- Location
- Colombia > Bogota : Building II
- Type
- Full-time
- Department
- Legal
- Seniority
- Manager
- Experience
- 7+ years
- Education
- Associate
- Closing date
- Today
- Source
- Workday
Description
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
Skills
Risk Management