Regulatory Affairs, Senior Associate – Mississauga

Roles and Responsibilities:

1. Prepare and submit various regulatory submissions in the CTD format to Health Canada.
2. Ensures that submissions are accurate, complete, and compliant with regulatory requirements.
3. Create, review, and maintain documents and standards within Regulatory Affairs.
4. Perform regulatory risk assessment by identifying, describing and estimating the risks affecting current and future development projects.
5. Prepare responses to questions raised by Regulatory Authorities or business partners in a timely manner and within deadlines.
6. Perform gap analysis on dossiers to identify weakness for ANDS submission to Health Canada
7. Communicate and coordinate with partners/manufacturers to obtain supporting documents for ANDS submission.
8. Responsible for assessing, coordinating, and compiling deficiency responses in a timely manner to deficiency questions from Health Canada
9. Preparing product labelling and monograph, as well as related items
10. Support internal and external groups to assist with product listing on all the provincial formularies
11. 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.
12. Evaluate proposed changes to development and marketed products for regulatory impact and liaise with internal/external stakeholders to assemble necessary documentation.
13. Assist in developing and maintaining various regulatory tracking tools.
14. Work closely with all functional groups (Business Development, Legal, Production, Quality, R&D) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.
15. Manage collaborations with external partner sites for new projects. Serve as main point of contact with third-party manufacturers for the projects led.
16. Maintains awareness of current regulatory environment and guidelines that impact the organization and share knowledge with internal stakeholders, as required.
17. Support implementation of QA systems and generation of Standard Operating Procedures.
18. Remain up to date on applicable regulatory guidelines (Health Canada, ICH, etc.).
19. Perform other duties as required or necessary

Any other duties as assigned by Senior Scientific Affairs Leadership team.

Major Tasks:

 

Submissions

• Reviewing dossiers shared by partner companies for regulatory submissions for completeness, accuracy and compliance with regulatory requirements and providing feedback to partners
• Reviewing Drug Master Files and providing gap assessments to partners.
• Preparation of regulatory submissions (CTD format) including compiling, writing, and publishing
• Negotiation with regulatory authorities to gain approval (NOC) and obtaining alignment from partners and other functional groups on responses
• Timely preparation and filing of submissions to support company needs
• Supervision and coordination with outside consultants, subject matter experts relating to the preparation of regulatory submissions and other related regulatory activities, as required.

 

New Product Assessments/ Product Launches

• Monitoring product development activities by interacting 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 of 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 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