Senior Manager, Regulatory Affairs

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 role 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 and is responsible for communicating and ensuring that the Lead, Regulatory Affairs is advised on key issues and updates. Combining knowledge of scientific, regulatory and business strategies, the SrMRA ensures the advancement and commercialization of AbbVie's products while maintaining compliance with Health Canada's regulatory policies, regulations and guidance documents.

Responsibilities

Direct, manage and oversee a team of Regulatory Affairs professionals and their activities; Provide strategic input and support the filing and approval with Health Canada of regulatory submissions; Strategically support and/or prepare the filing, approval, and post-approval activities of several types of regulatory submissions; Hold self and direct reports accountable for regulatory-related projects and ensure filing and approval timelines are met; Supervise, manage, support and mentor direct reports; Conduct mid- and year-end performance evaluations with each direct report; 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; Consult with the AbbVie Global Regulatory team to define filing strategies and provide Canadian regulatory guidance; Actively support and participate in brand team, early pipeline touch point, new product introduction (NPI) and launch readiness review (LRR) meetings; Work on Canadian labels and label artwork with global and affiliate teams; Manage RA activities related to product in-licensing, divestitures and/or acquisitions; Oversee timely data entry of submission documents into electronic data management systems; Support or manage regulatory activities related to special access program (SAP) requests, access to information requests and establishment licencing activities; Keep track of revisions to the Canadian Food and Drugs Act, regulations and related policies and guidelines; Support review and preparation of comments on Health Canada proposed/draft guidance documents; Support review and impact assessment of AbbVie Global's SOPs and update local SOPs; Actively support and lead internal and external inspections / audits; Advise management of regulatory-related activities that may impact filings and/or approvals; Operate in compliance with local regulations and company policies and procedures

Requirements

Bachelor's degree in Pharmacy, Biology, Pharmacology, or related Life Sciences; 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; 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; Advanced English skills; 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

Nice to have

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; Experience with Biologics, small molecules, medical devices, quality-related changes, and clinical trial applications