Senior Manager, Regulatory Affairs

AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology oncology neuroscience eye care virology womens health and gastroenterology in addition to products and services across its Allergan Aesthetics portfolio.

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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 AbbVies 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 AbbVies products while maintaining compliance with Health Canadas 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 Canadas 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 Globals 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 Guidances and policies open for consultation and communicate to management accordingly.
• Support the review and impact assessment of AbbVie Globals Standard Operating Procedures (SOPs) and update local SOPs as applicable.
• Be actively involved in AbbVie Globals 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 :

Education / Experience required

• Bachelors 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.

Essential Skills and Abilities

• 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

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

Additional Information :

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. 

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Work :

No

Employment Type :

Full-time