Senior Regulatory Affairs Manager

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.

Ability to execute highly complex or specialized projects.

Adapts precedent and may make significant departures from traditional approaches to develop solutions.

Main Responsibilities

• As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization 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.