Regulatory Affairs Manager

A long term client of ours is currently in search of a motivated Subject Matter Expert of Regulatory Affairs to join its growing Regulatory Affairs Department.

Our client specialize in pharmaceutical solutions and strategies to drug substance and drug product development. In this position, reporting to the Senior Director, Regulatory Affairs, you will be responsible for authoring premarketing regulatory submissions (PINDs, INDs, NDAs, ANDAs), post-approval supplements, annual reports, and controlled correspondence.

You will also be engaging in the review of source documents and preparing summaries of findings that relate to the areas of regulatory assessment necessary to ensure the scientific integrity of submissions and strict adherence to regulatory requirements.

Duties and Responsibilities

The key responsibilities for the role are the following:

Preparation and submission of regulatory documents, including PIND meeting packages, INDs, NDAs, ANDAs, regulatory correspondence and amendments, under oversight of the RA Director.

Critical evaluation of scientific documentation to identify potential risks and communicate them to appropriate functional areas.

Review and interpretation of regulatory guidelines and regulations to ensure compliance with US FDA, Health Canada and other international requirements.

Coordination of regulatory activities across different product development programs and projects organization, and maintenance of project files.

Development and maintenance of standard operating procedures or local working practices.

Work and develop professional relationships and act as a liaison with regulatory agencies.

Education Requirements:

M.Sc. in chemistry, pharmaceutics, chemical engineering, or related scientific field.

Required Experience and Skills:

5-7 years of experience in pharmaceutical development and regulatory affairs.

Ability to critically evaluate technical documents in support of the regulatory assessment.

Understanding aspects of drug development, including analytical methodologies and ANDA bioequivalence regulatory framework.

Good communication skills, team oriented, critical thinker, able to work in a collaborative environment.

Ability to analyze and provide science-based solutions, problem solving skills.

Proficiency in computer software use such as Microsoft, Excel, PowerPoint, and Project Management tools.