Regulatory Affairs Manager
The Regulatory Affairs Manager will oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Key responsibilities include interacting with regulatory agencies to expedite approval of pending registration, serving as regulatory liaison throughout the product lifecycle, and participating in product plan development and implementation.
This role requires strong attention to detail, solid communication skills, and ability to communicate at all levels.
Requirements:
* Minimum Level 8 Degree in Engineering or Science or related discipline.
* Minimum of 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.
Salary:
$83,000 - $110,000 per year
Job Description:
This Regulatory Affairs Manager position is responsible for managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than development, and you will typically handle short-term operational/tactical responsibilities.
You will serve 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.
For this position, it will be necessary to bring manufacturing operations and manufacturing change experience, people management experience, and experience resolving any issues regarding nonconformance.
Instructions:
Please submit your application with relevant qualifications and experience.
Estimated Salary Range:
$83,000 - $110,000 per year