Job Description
MAIN PURPOSE OF ROLE
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Regulatory Affairs.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
MAIN RESPONSIBILITIES
• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in 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 appr...