Job Description
The Position
For projects assigned by the Manager, Regulatory Affairs (RAM), the Environmental Compliance and Regulatory Associate independently prepares, reviews and files high quality documents and submissions on environment-related issues impacting animal health product and ensures company and product compliance through proactive interactions with Canadian/international BI personnel and the Canadian Authorities. Consults with management, business units and other functional areas with respect to Canadian environmental requirements, obligations and options. Also supports AH regulatory team as needed for regular pre- and post-approval regulatory files.
Responsibilities
- Proactively develops action plans and implements all activities to achieve compliance with environmental regulations affecting BI veterinary products within timelines prioritized and specified by the Canadian Animal Health Management Team and RAM.
- Leads interactions on environmental issues involving AH products between Canadian/international BI personnel and Environment and Climate Change Canada (ECCC), the Canadian Animal Health Authorities (CFIA & VDD) and industry associations or other outside non-governmental organizations.
- Identifies and prioritizes issues that may impact the importation and distribution of BI veterinary products, such as regulations on plastic containers (including labeling requirements), PFAS, new substance reporting and environmental impact and other new requirements.
- Work closely with the marketing departments, the business units and QA/Logistics/Supply Chain Management to support business needs by establishing priorities and plan submissions, address gaps and exchanging information on environmental dossier compliance, including proposing viable solutions to issues.
- Supports the RA team for regulatory dossiers to the VDD and CFIA, as well as other regulatory tasks, as determined by the RAM
- Ensures entry and quality of product documentation for Canadian AH products in corporate validated systems.
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
- Bachelor’s Degree (Biochemistry, Biology, Biopharmaceuticals, Chemistry, Environmental Science, Medicine, Pharmacology, Veterinary Medicine)
- Excellent Project Management skills, i.e. superior organizational, written and oral communication skills, the ability to work independently as well as to collaborate effectively with team members locally and internationally to meet strict deadlines.
- Thorough knowledge and understanding of the Canadian Environmental Protection Act (CEPA) and ECCC regulations that apply to development, manufacturing and distribution of pharmaceutical, veterinary health products and biological products.
- Knowledge of GMPs, Food and Drug Regulations & CFIA biologics regulations an asset.
- Good working knowledge of business office software applications including Microsoft Office Word, Excel, PowerPoint and capacity to be trained to use specialized databases.
- Strong attention to detail and follow-up, excellent organizational, time management, interpersonal, written and oral communication skills.
- Good data analysis capacity.
- Excellent interpersonal skills with ability to work harmoniously with diverse teams (cross-functional collaboration).
- Multitask in a fast paced, changing environment.
- Ability to influence without authority.
- Understand and apply "Our Behaviours", as defined by the company.
- Strong communication skills.
- Internal networking ability.
- Ability to change and innovate.
- Basic knowledge of medical terminology. Fluent in English; knowledge of French an asset.
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 December 4, 2024.
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