Opening for Regulatory Affairs Manager : Intertek, Canada

Organization :Intertek

Job Title : Regulatory Affairs Manager

Location : Mississauga, ON Canada

Qualification : Minimum B.Sc. (advanced Science university degree, e.g., Pharmacology, Pharmacy or related discipline preferred)

Experience : 

• Minimum of 6 years regulatory experience in Regulatory Affairs.
• Thorough knowledge of new product and process development, current regulatory issues in Canada, United States, and Europe.
• 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.
• Demonstrated leadership ability.

Job Responsibility : 

As Regulatory Affairs Manager, you will work with other in-house Regulatory Affairs professionals in the day-to-day issues associated with regulatory affairs, such as working actively on projects, writing domestic and international regulatory submissions and strategy documents as well as directing compliance audits and keeping abreast of ongoing changes in regulatory and compliance policies and procedures.

As a member of the Pharmaceutical & Healthcare Group, you will:

• Provide global regulatory affairs consultative support.
• Manage and participate in the writing and preparation of eCTD compliant submissions and regulatory filings related to Rx and OTC drugs (including biologics), medical devices, Natural Health Products, cosmetics, and veterinary drugs.
• Review documents for IND/CTA, NDA/NDS, IDE/510(K)/PMA, PLA, etc. and associated amendments/supplements. This includes the evaluation, and interpretation of proprietary and published safety, efficacy, and quality data. Recommend changes for labelling, manufacturing and marketing for regulatory compliance.
• Be responsible for the management and quality control of regulatory projects.
• Participate in regulatory agency meetings.
• Develop global product strategies for new products.
• Keep abreast of regulatory procedures and changes by attending regulatory conferences.
• Supervise regulatory affairs staff.
• Project manager responsible for regulatory affairs projects being delivered to clients on time, on spec and on budget. Prepare proposals and project budgets to present to clients.
• Assist with the preparation of business development plans for the regulatory affairs area and for the Pharmaceutical and Healthcare Group. 

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