Senior Manager Regulatory Affairs

MAIN PURPOSE OF ROLE :

• Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
• First level manager of a work team that may comprise professionals, technical and/or administrative staff.
• Typically without budget or hire/fire authority.
• Focuses on mentoring, coaching, and coordination.

MAIN RESPONSIBILITIES :

• As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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 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.

QUALIFICATIONS :

Education

• Associates Degree ( 13 years)

Experience/Background

• Minimum 4 years