Regulatory Affairs Manager
We are seeking a highly skilled Regulatory Affairs Manager to join our team at {company}. The successful candidate will be responsible for managing teams within the Regulatory Affairs Sub-Function, with a focus on policy and strategy implementation and control.
About the Role
The core responsibilities of this position include:
* Overseeing the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
* Interacting with regulatory agencies to expedite approval of pending registration.
* Serving as regulatory liaison throughout the product lifecycle.
* Participating in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
* Ensuring timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
* Serving as regulatory representative to marketing, research teams, and regulatory agencies.
* Advising development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Key Responsibilities
To be successful in this role, you will need to bring:
Requirements
For this position, we require:
Salary
$124,400 - $168,000 per year.