Senior RA Associate

ACIC Pharmaceuticals Inc.

Brantford, ON

Position Description

Reporting directly to the Vice President-Scientific Affairs, the Senior Regulatory Affairs and Quality Assurance Associate will be responsible for leading regulatory submission projects for the US market and supporting quality assurance activities of marketed products.

Regulatory Responsibilities
• Plan, coordinate, author, compile and file new and post approval generic drug product submissions for the Canadian and US Market
• Liaise with Regulatory Agencies on all aspects of the drug submission including pre-submission/ scientific advice meetings, controlled correspondences, deficiencies and following up on review status and project updates.
• Work on complex projects which involve anticipating obstacles, developing solutions and resolving issues in a timely manner.
• Review and approve various product labeling components and marketing materials.
• In consultation with management, provide regulatory guidance and expertise to other areas of the business and our... More Detail

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