Intertek, a leading provider of ATIC (Assurance, Testing, Inspection and Certification) Services, is looking for a Sr. Regulatory Affairs Associate to join our Health, Environmental and Regulatory Services team located in Mississauga, Ontario.
Intertek Health, Environmental and Regulatory Services (HERS) delivers expert advice and practical solutions through its global network of subject-matter experts focused on delivering expert scientific, toxicological, and regulatory services.
- As a Senior Regulatory Affairs Associate, you will work with other in-house Regulatory Affairs professionals in the day- to day issues associated with regulatory affairs, such as oversee the preparation of domestic and international regulatory submissions and keep abreast of ongoing changes in regulatory and compliance policies and procedures.
As a member of the Pharmaceutical & Healthcare Group, you will:
- Provide regulatory affairs consultative support, develop, and implement regulatory strategic plans
- Liaise with internal and external groups to collect necessary documents/information, and participate in the writing, review, and preparation of eCTD compliant submissions and regulatory filings related to prescription and non-prescription drugs (including biologics), cosmetics and veterinary drugs, and associated amendments/supplements to Health Canada, US, and other Regulatory Agencies
- Review drug advertising and promotional material for US and Canada
- Recommend changes for labeling, manufacturing, and marketing for regulatory compliance
- Initiate and manage regulatory affairs projects, within specified timeframes, ensuring accurate content, and quality control of each project
- Attend regulatory meetings and conferences; follow emergence of new regulatory requirements and their impact on regulatory projects.
- 5+ years regulatory affairs experience in an industry or government setting
- Thorough knowledge of new product and process development, current regulatory issues in Canada, and United States
- Good technical writing skills and the ability to review and critique safety, efficacy, and quality
- Excellent interpersonal skill and organizational, time management, and communication skills are essential
- Computer literacy in Microsoft Office and Adobe Acrobat
- RAC certification preferred
- eCTD submission experience preferred
- Minimum B.Sc., in life sciences
- Post- graduate education in regulatory affairs
Intertek Canada offers a salary and benefit package competitively placed with the local market. We promote a culture where motivated customer-oriented employees can flourish, experience professional fulfillment and reach their highest potential. Medical, Prescription, Dental, Vision, and Disability Insurance plans; RRSP plan with company match; paid time off (vacation; sick holiday); Employee Assistance Program (EAP); Tuition Reimbursement, and more.