Senior Manager, Regulatory Affairs

• 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.

Qualifications

• Bachelor's degree in Pharmacy, Biology, Pharmacology, or related Life Sciences is required
• Preferred Master of Science degree or Doctorate in Biochemistry, Biology, Microbiology, Chemistry, Toxicology, Pharmacology or in Management, such as a Master of Business Administration degree, is considered an asset.
• Minimum of ten years of experience in the pharmaceutical industry
• Minimum of four years of experience in leading a team of professionals
• Proven success in the preparation, filing, and approval of various submission types with Health Canada, and established negotiation and networking skills
• Developed expertise in the field of Regulatory Affairs, and a good understanding of the Business environment, products, and service areas
• Experience with Biologics, small molecules, medical devices, quality-related changes, and clinical trial applications are an asset
• Developed working knowledge and understanding of the Canadian Food and Drugs Act and Regulations, its policies, and related guidelines, including a basic understanding of the FDA and EMA, CHMP, MHRA regulatory requirements.
• Experience in leading and developing regulatory strategies
• Excellent organizational, project management, negotiation, and interpersonal skills
• Comfortable and efficient working in a matrix environment
• Computer proficient
• Experience with electronic regulatory submissions.

• AbbVie aims to offer a French-speaking workplace in Quebec and has made efforts to limit English requirements. However, advanced English skills are essential for this role because the position involves working with English-speaking employees, clients, and regions outside Quebec.

• Team player with experience in managing, coaching and mentoring employees
• Ability to take key action and demonstrate behavioural anchors that support all AbbVie core and leadership competencies.

Additional Information

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html