AbbVie Manager, Regulatory Affairs in St. Laurent, Canada
Manager, Regulatory Affairs
Canada, Quebec, St. Laurent
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn
Under the supervision of the Senior Manager, Regulatory Affairs, the Manager, Regulatory Affairs is responsible for a team of Regulatory Affairs professionals. In addition to managing the activities of direct reports (including training and coaching), the Manager, Regulatory Affairs is actively involved in the filing and approval with Health Canada of various types of Regulatory submissions in support of AbbVie’s development and marketed products pipeline. These responsibilities are carried out in collaboration with key global and affiliate AbbVie stakeholders (e.g., Regulatory, Commercial, Market Access, Medical, Pharmacovigilance, and Research & Development).
Combining knowledge of scientific, regulatory and business strategies, the Manager, Regulatory Affairs ensures the advancement and commercialization of AbbVie’s products while maintaining compliance with Health Canada’s regulatory policies, regulations and guidances.
• File and or/support the filing of various types of Regulatory submissions including, but not limited to, Clinical Trial Applications (CTAs) and CTA Amendments, New Drug Submissions, Supplemental New Drug Submissions, and Notifiable Changes.
• Hold self and all direct reports accountable for Regulatory-related projects and ensure Regulatory submission filing and approval timelines are met.
• Keep Management abreast of all Regulatory-related activities, especially those that may impact the outcome of filings and/or approvals.
• 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.
• Review and assist in the evaluation of supportive filing documentation for conformance with Health Canada’s Food and Drugs Act and Regulations, Policies and Guidelines.
• Support the various Brands / Brand Teams by understanding all aspects of the business and by sharing regulatory-related decisions, initiatives, issues and updates with Management and the Regulatory Team.
• Liaise with Global Regulatory to define filing strategies and provide Canadian Regulatory guidance for assigned projects.
• Supervise, train and coach direct reports. Ensure all direct reports are actively working on key AbbVie corporate goals/projects, and that compliance of currently approved and commercialized products is maintained.
• Conduct mid- and end of year performance evaluations with each direct report and provide constructive feedback on a continual basis.
• Support the review and impact assessment of global Standard Operating Procedures (SOPs) and update local Regulatory Affairs SOPs, as applicable.
• Read, understand and comply with assigned trainings and ensure direct reports complete assigned trainings within pre-established deadlines.
• Oversee and ensure the timely data entry of all submission documents into the affiliate and global electronic data management systems.
• Keep abreast of revisions and updates to the Canadian Food and Drugs Act; Regulations and related Policies and Guidelines.
• Support the review and preparation of comments to new “proposed/draft” Health Canada Guidance’s and Policies, and communicate to Management accordingly.
• Operates in compliance with local regulations and company policies and procedures.
• Bachelor’s Degree (e.g., pharmacy, biology, pharmacology) or related life sciences.
• Preferred M.Sc. or Ph.D. in Biochemistry, Biology, Microbiology, Chemistry, Toxicology, Pharmacology or in Management such as an MBA, etc.
• Minimum 5 – 8 years of experience in the pharmaceutical industry.
• 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.
• Expertise in the field of Regulatory Affairs, and very good understanding of the Business environment, culture, products and service areas.
• Experience with biologics, small molecules, medical devices, quality-related changes, and clinical trial applications are an asset.
• Developed knowledge and understanding of the Canadian Food and Drugs Act and Regulations, its Policies and related Guidelines.
• Experience in leading and developing Regulatory strategies.
• Excellent oral/written communication skills, organizational and interpersonal skills.
• Comfortable and efficient working in a matrixed environment.
• Computer literate. Experience with electronic regulatory submissions is an asset.
AbbVieis an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
Posting End Date: February 25, 2019
Job Type: Experienced