Regulatory Affairs Manager

Primary Functions:

The Manager of Regulatory Affairs is responsible for formulating, managing and executing strategies in order to achieve the objectives of the Regulatory Department. This could include management of regulatory staff and regulatory consultants who may undertake specific projects of both a medical and regulatory nature. The Manager is also responsible for developing and maintaining a close working relationship with Marketing, Sales, Quality Assurance, Project Management, Business Development, Clinical Research, Supply Chain Management and Labelling Team so that drug development, filing of submissions and maintenance of product compliance, are undertaken in a timely manner, consistent with applicable Federal and Provincial Regulations.

ROLES AND RESPONSIBILITIES:

• Managing and leading the team on New Product Registrations, Labeling and Post approval submissions with Health Canada.
• Development and maintenance of excellent working relationships with Health Canada, aiding in the potential reduction of filing requirements and timeliness of approvals, which significantly impact on the company’s competitive position within the industry.
• Assist in training fellow Associates on Regulatory due diligence, API selection pathway, submission strategies, CEP requirements, parameters impacting Drug Product formulation, Clinical studies overview and assisting them in career growth.
• Perform gap analysis on dossiers to identify weakness for ANDS submission to Health Canada
• Communicate and coordinate with partners/manufacturers to obtain supporting documents for ANDS submission. Provide scientific insight on New Product development and Technology Transfer Projects.
• Responsible for assessing, coordinating and compiling deficiency responses in a timely manner to deficiency questions from Health Canada
• Preparing / reviewing product labelling and monograph, as well as related items
• Support internal and external groups to assist with product listing on all the provincial formularies
• Responsible for post-market product administration, participating in the review and evaluation of planned changes for impact on regulatory submissions, identifying regulatory filing requirements and recommending regulatory agency and customer notification strategies/plans in the affected regulatory jurisdictions.
• Preparing SOP’s and work instructions, training programs on new regulatory guidelines, GMP, database management.

Major Tasks:

Submissions

• Reviewing dossiers shared by partner companies for regulatory submissions to ensure completeness, accuracy, and compliance with regulatory requirements, and providing feedback to partners.

• Reviewing Drug Master Files (DMFs) and conducting gap assessments for partners.

• Preparing regulatory submissions, including compiling, writing, and publishing submission documents.

• Negotiating with regulatory authorities to obtain approvals (NOCs) and coordinating alignment with partners and cross-functional teams on regulatory responses.

• Preparing and filing submissions in a timely manner to support business objectives and regulatory timelines.

• Supervising and coordinating external consultants and subject matter experts involved in the preparation of regulatory submissions and related regulatory activities.

New Product Assessments/ Product Launches

• Monitoring product development activities by interacting with contract manufacturers as necessary against identified submission targets.
• Provide impact regarding formulation of drug development, clinical development etc. Initiation of Change Controls for changes from submission documents to launch documents, for handover to Quality Department.

Labelling

• Review and approve artwork routings of labelling

Compliance

• Ensure continual regulatory compliance with all products due to changes initiated from HC (e.g. Labeling, Quality, changes)
• Help to develop and oversee procedures and processes within Regulatory Operating Procedures to ensure compliance with applicable regulations (e.g. Working Instructions are up to date, SOPS are followed etc.)
• Assist in development and maintenance of accurate databases
• Overseeing the timely preparation of activities for other functional groups (SAP codes creations, launch documentation packages

• Training and supervision of Regulatory Staff

Other duties as assigned by the Vice President, Regulatory Affairs.