Job Description

THE POSITION
Associate, Established Products and Regulatory Operations

• In collaboration with the Manager, to plan, manage and coordinate the filing and approval of high quality regulatory submissions of established products to Health Canada and ensure product compliance through relevant regulatory registrations and interactions/negotiations with internal stakeholders and Health Canada. Responsible for independently managing and performing the activities and interactions with the Central Service Unit (CSU) related to the compilation and archiving of high-quality regulatory submissions in a timely manner for all BI HP products.

Sr. Associate, Established Products and Regulatory Operations

• Independently, to plan, manage and coordinate the filing and approval of high quality regulatory submissions of established products to Health Canada and ensure product compliance through relevant regulatory registrations and interactions/negotiations with internal stakeholders and Health Canada. Responsible for independently managing and performing the activities and interactions with the Central Service Unit (CSU) related to the compilation and archiving of high quality regulatory submissions in a timely manner for all BI HP products. Responsible for the implementation of Health Canada's operational initiatives for digitization.

Responsibilities
Associate, Established Products and Regulatory Operations

• Project management:

o Independently maintain submission publishing process standards, execute and monitor/track progress of submission plans to effectively meet submission deadlines, by interacting with relevant stakeholders, and liaising with CSU (third party) to track progress against these plans.
o Review compilation and publishing plans to ensure compliance with applicable Health Canada regulations and guidelines, as well as BI Regulatory Operations work practices and guidelines.
o Provide business support for the workflow of regulatory submission documents through the document management system, including archiving (hard copy and electronic copy).
o Under close supervision of the Manager, develop project/action plans and implement all activities as directed, to achieve the timely and efficient registration of high quality submissions of Established HP Products (post-market variations) within timelines specified by Corporate Office or local Management. * Continuous Improvement:
o Foster operational excellence by keeping the department and Global Regulatory Operations team(s) informed on Health Canada eCTD/non-eCTD updates and ongoing Health Canada Pilot projects as well as its potential business impact.
o Lead/user for many RA systems (VEEVA, BIRDS, IDEA, SLCI (AMT/RSPP), identifying business/user requirements, testing and participating in the completion of appropriate systems documentation.
o Participate in the development and implementation of standards, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation and conduct associated trainings; recommend and help implement associated process improvements. * Technical Expertise:
o Provide expertise in electronic information management and submission tools and strategies to assist other members of Regulatory Affairs and third party (CSU) during submission preparation and delivery.
o Utilizes systems, tools and key technologies for electronic document capture, generation, manipulation, scanning, and QC. * Quality:
o Maintain and administer in a timely manner the global regulatory information and documentation databases/systems to ensure all KPIs are met (CPD3, RSPP).
o As directed, responsible for the review and timely response for the Access to Information Requests received by Health Canada (E2B reports).
Sr. Associate, Established Products and Regulatory Operations

• Project management:

o Independently maintain submission publishing process standards, execute and monitor/track progress of submission plans to effectively meet submission deadlines, by interacting with relevant stakeholders, and liaising with CSU (third party) to track progress against these plans.
o Review compilation and publishing plans to ensure compliance with applicable Health Canada regulations and guidelines, as well as BI Regulatory Operations work practices and guidelines.
o Provide business support for the workflow of regulatory submission documents through the document management system, including archiving (hard copy and electronic copy).
o Independently, develop project/action plans and implement all activities, to achieve the timely and efficient registration of high quality submissions of Established HP Products (post-market variations) within timelines specified by Corporate Office or local Management. * Continuous Improvement:
o Foster operational excellence by keeping the department and Global Regulatory Operations team(s) informed on Health Canada eCTD/non-eCTD updates and ongoing Health Canada Pilot projects as well as its potential business impact.
o Lead/user for many RA systems (VEEVA, BIRDS, IDEA, SLCI (AMT/RSPP), identifying business/user requirements, testing and participating in the completion of appropriate systems documentation.
o Participate in the development and implementation of standards, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation and conduct associated trainings; recommend and help implement associated process improvements. * Technical Expertise:
o Lead, plan and implement HC digital initiatives while strengthening relationships and partnership with HC. Develop local processes in accordance with HC's directives and in compliance with global systems.
o Provide expertise in electronic information management and submission tools and strategies to assist other members of Regulatory Affairs and third party (CSU) during submission preparation and delivery.
o Utilizes systems, tools and key technologies for electronic document capture, generation, manipulation, scanning, and QC.
o Train and on-board new DRA colleagues regarding all operational aspects and processes. * Quality:
o Maintain and administer in a timely manner the global regulatory information and documentation databases/systems to ensure all KPIs are met (CPD3, RSPP).
o As directed, responsible for the review and timely response for the Access to Information Requests received by Health Canada (E2B reports).
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.
Requirements
Associate, Established Products and Regulatory Operations

• Bachelor's degree in life science and/or computer science or equivalent work experience in drug regulatory affairs in the pharmaceutical industry/health authority (2-3 years) is required. Certificate in Canadian Drug Regulatory Affairs from recognized institution is an asset.
• Sound knowledge of the Canadian Food and Drugs Act and Regulations, and Health Canada policies and guidelines.
• Thorough knowledge of eCTD/NeeS experience/understanding (experience with word processing and publishing tools).
• Advanced knowledge of electronic filing and archiving systems in document management system as well as other business office software applications (e.g Microsoft Word, Outlook).
• Strong attention to detail and solid excellent project management skills,
• Excellent planning, organizational and time management skills.
• Strong communication and negotiation skills.
• Ability to work independently or in a team environment, to complete work within strict deadlines.

Sr. Associate, Established Products and Regulatory Operations

• Bachelor's degree in life science and/or computer science or equivalent work experience in drug regulatory affairs in the pharmaceutical industry/health authority (4-5 years) is required. Certificate in Canadian Drug Regulatory Affairs from recognized institution is an asset.
• Sound knowledge of the Canadian Food and Drugs Act and Regulations, and Health Canada policies and guidelines.
• Thorough knowledge of eCTD/NeeS experience/understanding (experience with word processing and publishing tools).
• Advanced knowledge of electronic filing and archiving systems in document management system as well as other business office software applications (e.g Microsoft Word, Outlook).
• Strong attention to detail and solid excellent project management skills,
• Excellent planning, organizational and time management skills.
• Strong communication and negotiation skills.
• Ability to work independently or in a team environment, to complete work within strict deadlines.

Total Rewards
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.
Visit https://www.boehringer-ingelheim.com/ca/careers/benefits-rewards
READY TO APPLY?
Click the "Apply Now" button below to submit your application. We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted. 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. If you require accommodation, we will work with you to meet your needs.
DEADLINE FOR APPLICATIONS
Applications for this position will be accepted until May 9, 2025.
Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.