Regulatory Affairs Operations Manager

The Position To ensure continued regulatory life-cycle support of established products to achieve and maintain registrations in line with commercial objectives and in compliance with all Canadian Regulatory and legal obligations maximizing business potential ( e.g. through Loss of Exclusivity (LoE) strategies). To provide Competitive and Regulatory Intelligence to support local strategies and shape Boehringer Ingelheim Canada's policy for implementation and integration into current business practices. To lead and oversee the management and coordination of regulatory operational activities related to our human pharmaceutical products.

Regulatory Policy and Innovation:
As an expert in understanding and working knowledge of Regulatory Requirements, policies and regulations, monitor changes to the regulatory environment (Act, regulations, guidelines, policies, etc.) and provide a critical assessment of impact and strategic advice to shape Boehringer Ingelheim Canada's regulatory policy and communicate impact locally and globally.
Communicate cross functionally the insights, regulatory trends and their potential impact on business and strategic plans.
Monitor the Health Canada regulatory changes and redesign the Boehringer Ingelheim Canada's business model of interactions with Health Canada to ensure compliance.
Lead initiative to facilitate standardization and consolidation of Boehringer Ingelheim Canada's comments on draft regulations/guidelines/policy documents.
Partner with key business stakeholders to identify gaps and provide needed assessments or presentation on the Regulatory Environment to the leadership team and other functions to support local strategic planning and maximizing our business potential.
Participate in the training of Drug Regulatory Affairs (DRA) staff on new regulatory environment changes and impact on Boehringer Ingelheim Canada.
Participate in industry association initiatives/projects, as needed.
Participate in the development of concepts to align Regulatory Affairs with internal functions to be best prepared for changes in the external environment (e.g. Artwork Development, Quality Assurance, digitization initiatives, etc..).
Proactive planning, coordination, integration and management of all activities required to achieve the timely and efficient maintenance of Established BI products in Canada within timelines specified by corporate and local management. Accountable for the execution of all relevant critical evaluation of data, including Loss of exclusivity (LOE)activities, assessment and advance identification of issues, supporting planning and evaluation by direct reports of their projects to ensure sustained business potential for established products.
Responsible for driving efficient compilation, filing and negotiation of life-cycle management submissions within timelines specified by Corporate Office or local Management
Contributing to the development and implementation of creative strategies for the presentation and negotiation of life cycle submissions with Health Canada to ensure approvals are granted expeditiously and optimal timelines are secured to ensure continued product supply.
Access to information (ATI) requests, electronic submissions, Regulatory Intelligence (RI) process, Comments on Regulations and Guidelines, Annual Drug Identification Numbers (DIN) notification, Product Withdrawals, Commitment tracking,etc...)
Overseeing the management of Certificates of Pharmaceutical Product (CPP) requests and Global Site Master File/Drug Master File (DMF) submissions within specified time lines to support global business and third party business needs.
Scientific and Technical Support:
Provide scientific and technical guidance on the overall suitability of scientific documents to support lifecycle changes to established products.
Identify scientific and technical deficiencies and recommend actions based on scientific expertise.
Responsible for recommendations directly influencing decisions on the technical adequacy of responses to critical Health Canada (HC) questions and queries for complex applications for established products (e.g. site transfers).
Quality and Efficiency:
Review submission content prior to submission for completeness and ensure that submission content is in accordance with appropriate quality and compliance standards (legal, regulatory and company requirements).
Ensures the Operations team executes all deliverables and functions, meeting or exceeding requirements for timeliness, and accuracy as well as meeting department standards for productivity, quality and compliance.
• Identifies regulatory submission process improvements and establishing processes utilizing key technologies. • Responsibility for meeting Key Performance Indicators for input into Corporate and local data systems (e.g. Corporate Product Database (CPD), Request for Supply Production Planning (RSPP), Artwork Management Tool (AMT), Corporate Company Data Sheet (CCDS) tracking)
Actively seek, promote and implement new ideas/solutions by team to improve product life-cycle management, daily operations, and monitor internal practices to ensure all of the organization's regulatory operations remain in compliance with government guidelines and regulations.
Corrective And Preventive Action (CAPA) lead and ensuring compilation of Non Compliance (NC) action plans.
Lead the implementation of all digital transformation initiatives in line with Global Regulatory Operations and business priorities and needed.
Networking:
Establish, foster and maintain close working relationships and liaise effectively with internal departments Global Regulatory Affairs (GRA), Legal, Marketing, Regulatory Affairs team, Pharmacovigilance (PV) and Operations and external stakeholders), by building partnerships with internal/external stakeholders to be viewed as a competent resource.
Establish external networks to support Health Canada engagement through participation in Pilot Projects to support Health Canada’s Digital transformation.
Leading the interactions between Canadian/International Boehringer Ingelheim personnel as well as Health Canada with respect to the related Regulatory activities
Talent management: responsible for developing and coaching employees to better meet the needs of their current and future roles as well as the future needs of Boehringer Ingelheim Canada by facilitating appropriate development opportunities and providing timely feedback regarding strengths and development needs.
This position is based in the Burlington, Ontario office located at 5180 South Service Road and is flexible.
Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.

University degree in a scientific field (B.Sc) required, advanced post-graduate degree is an asset (M.Post-Graduate RA/QA Certificate is an asset
Demonstrated experience in Regulatory Affairs in the Pharmaceutical Industry.
Excellent organization, time management, and written/verbal communication skills
Strong attention to detail and solid Project Management skills.
strong analytical aptitudes, skills and capacity to assess and summarize scientific data and regulatory situations; strong writing skills
Strong technical knowledge of the Canadian Food & Drugs Act and Regulations,
Good understanding of Quality related functions is considered an asset
Strong knowledge of Chemistry Manufacturing and Controls (CMC) regulations and Canadian policies/guidelines; good knowledge of other regions regulatory environment (USA/FDA & Europe/EMEA)
Computer skills (i.e. MS Office,Outlook, PowerPoint, Word, Excel, Adobe Suite, electronic submissions), and familiarity with digital technologies.
Proven leadership skills, thorough knowledge of principles and practices related to people management, program planning and human resource utilization.
Team player, able to multi-task under tight deadlines and work with minimal supervision, ability to work on multiple projects at one time
Demonstrated experience in Regulatory Affairs in the Pharmaceutical Industry.
Excellent organization, time management, and written/verbal communication skills
Strong attention to detail and solid Project Management skills.
strong analytical aptitudes, skills and capacity to assess and summarize scientific data and regulatory situations; strong writing skills
Strong technical knowledge of the Canadian Food & Drugs Act and Regulations,
Good understanding of Quality related functions is considered an asset
Strong knowledge of Chemistry Manufacturing and Controls (CMC) regulations and Canadian policies/guidelines; good knowledge of other regions regulatory environment (USA/FDA & Europe/EMEA)
Computer skills (i.e. MS Office,Outlook, PowerPoint, Word, Excel, Adobe Suite, electronic submissions), and familiarity with digital technologies.
Proven leadership skills, thorough knowledge of principles and practices related to people management, program planning and human resource utilization.
Team player, able to multi-task under tight deadlines and work with minimal supervision, ability to work on multiple projects at one time
We offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.
Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. Applications for this position will be accepted until January 9, 2026