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.