Regulatory Affairs Manager North Africa

MAIN PURPOSE OF THE 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...