NEW JOB POSTING: Regulatory Affairs Associate

Reporting to the Vice-President, Quality and Regulatory Affairs, the Associate will support all regulatory activities for complete product life-cycle. Responsibilities and duties include but are not limited to those described below:

Key Responsibilities and Primary Duties:

Key Responsibility: Preparation and Maintenance of Regulatory Registration

With guidance:

• Prepare and submit all aspects of pre-market and post-market dossiers which include but are not limited to ANDS, NOS, DIN, Notifiable Changes, Supplements and annual changes.
• Liaise and orchestrate meetings with cross functional departments and strategic partners to ensure timely submissions.
• Critically review technical documents that support submissions.
• Prepare responses to questions from Health Canada or other agency.
• Prepare, review and approve product artwork and labels (including arranging French translation)
• Author product specifications, method transfer protocols, transportation protocols or pharmaceutical equivalence protocols, as necessary.
• Source, assemble and ship study supplies.
• File and maintain foreign sites on MDA's Drug Establishment License.
• Prepare and file PCPA and provincial formulary submissions
• Prepare tech transfer of approved submission documents to Quality upon NOC.
• Track and ensure the successful completion of post-approval commitments.
• Support product launch activities.
• Assess impact of post-approval changes in regards to approved submissions and project manage the receipt of supporting data and documentation.
• Provide administrative and related project support including materials for pre-submission meetings, submission dossier publishing and structure-product-labelling
• Maintain MDA's regulatory filing system
• Other duties as directed.

Qualifications

Educational Requirements:

• Minimum Bachelor of Science Degree
• Graduate of Regulatory Affairs Postgraduate Certificate Program (preferred)

Industry Experience:

• Minimum 1 year experience in quality systems or regulatory affairs within the pharmaceutical industry, specific experience with parenteral products is preferred.
• Sound knowledge and application of Canadian regulations.

Special Skills:

• Ability to work collaboratively in a professional and effective manner across MDA departments and with external partners.
• Strong investigation and problem-solving skills
• Strong project management skills (manage and prioritize multiple tasks)
• Ability to plan and organize available resources and activities in-order to reach predefined goals
• Experience in using computer programs (MS Word, Excel, and Access)
• Strong verbal and written communication skills
• Ability to respond quickly to a changing regulatory environment