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The Senior Manager, Regulatory Affairs (SrMRA) is responsible for the direction, management and oversight of a team of Regulatory Affairs professionals and their respective activities. The Senior Manager, Regulatory Affairs also provides strategic input and actively supports the filing and approval with Health Canada of various types of regulatory submissions in support of AbbVie’s development and marketed products portfolio, including medical devices. These responsibilities are carried out in collaboration with internal stakeholders (e.g., AbbVie affiliate and Global Regulatory Affairs, Commercial, Market Access, Medical Affairs, Pharmacovigilance, and Research & Development teams). The SrMRA actively supports brand teams on assigned projects, by understanding all aspects of the business, and by sharing regulatory-related decisions, initiatives, issues, and updates with team members in a timely fashion. The SrMRA is also responsible for communicating and ensuring that the Lead, Regulatory Affairs is advised on key issues and updates discussed at the early pipeline touchpoints, brand teams, New Product Introduction (NPI), and Launch Readiness Review (LRR) meetings.
Combining knowledge of scientific, regulatory and business strategies, the Senior Manager, Regulatory Affairs ensures the advancement and commercialization of AbbVie’s products while maintaining compliance with Health Canada’s regulatory policies, regulations and guidance documents.
Key responsibilities
- Strategically support and/or prepare the filing, approval, and post-approval activities of several types of regulatory submissions including, but not limited to, clinical trial application activities, new drug submissions supplemental new drug submissions, notifiable changes, and medical device-related submissions.
- Hold self and all direct reports accountable for regulatory-related projects and ensure regulatory submission filing and approval timelines are met.
- Supervise, manage, support and mentor direct reports.
- Conduct mid- and year-end performance evaluations with each direct report and provide timely constructive feedback on a regular basis.
- Review and assist in the evaluation of regulatory submission documents for conformance with Health Canada’s Food and Drugs Act, regulations, policies, and guidelines.
- Support the preparation and conduct of pre-submission meetings with Health Canada. This includes, but is not limited to, the preparation of pre-meeting materials and presentations.
- Consult with the AbbVie Global Regulatory team to define filing strategies and provide Canadian regulatory guidance for assigned projects.
- Actively support and participate in brand team meetings, as applicable.
- Actively support and assist in early pipeline touch point meetings, as applicable.
- Actively participate in new product introduction (NPI) and launch readiness review (LRR) meetings and provide timely regulatory updates, as applicable.
- Work with the AbbVie Global’ Strategic Labelling team, the AbbVie Global Regulatory Affairs team, the Global Labelling Management team, and the affiliate brand teams to develop competitively differentiated Canadian labels and label artwork.
- Manage RA activities related to product in-licensing, divestitures and/or acquisitions.
- Oversee and ensure the timely data entry of all submission documents into the Canadian Affiliate and AbbVie Global’s electronic data management systems.
- Support or manage regulatory activities related to special access program (SAP) requests, access to information requests and establishment licencing activities
- Read, understand and comply with assigned trainings and ensure direct reports complete assigned trainings within pre-established deadlines.
- Keep track of revisions and updates made to the Canadian Food and Drugs Act; regulations and related policies and guidelines as these pertain to Regulatory activities.
- Actively support the review and preparation of comments to new Health Canada “proposed/draft” Guidance’s and policies open for consultation, and communicate to management accordingly.
- Support the review and impact assessment of AbbVie Global’s Standard Operating Procedures (SOPs) and update local SOPs, as applicable.
- Be actively involved in AbbVie Global’s regulatory initiatives, as applicable.
- Actively support and lead internal and external inspections / audits.
- Advise management of all regulatory-related activities, especially those that may impact the outcome of filings and/or approvals.
- Operate in compliance with local regulations and company policies and procedures.