CMC Manager

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

Education Level

Major/Field of Study

Or

Education Level

Associates Degree (± 13 years)

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Experience/Background

Experience

Experience Details

Minimum 4 years