Regulatory Affairs Assistant

REGULATORY AFFAIRS ASSISTANT

Are you looking to join a dynamic team where collaboration, innovation, and well-being are priorities? Are you passionate about the pharmaceutical and food industries and seeking a new challenge to leverage your expertise? Macco Organiques is growing and is looking to hire a Regulatory Affairs Assistant to expand its team.

Macco Organiques is a facility located in Valleyfield, specializing in the production of food and pharmaceutical-grade chemicals for over 35 years.

Benefits of working at Macco Organiques Inc.

• Competitive salary and vacation time;
• Employee benefits program and pension plan;
• Employee assistance program;
• Work-life balance;
• Company events and team activities.

Role and Responsibilities

• Ensure regulatory tracking of products, processes, or technologies in development;
• Prepare, update, and maintain regulatory documentation;
• Collect, validate, and organize information needed for regulatory submissions;
• Ensure compliance of products according to current regulatory requirements;
• Conduct regulatory monitoring to identify changes that may impact the company's activities;
• Serve as an internal resource for questions related to regulatory requirements;
• Perform administrative and documentary follow-ups related to regulatory files;
• Participate in the preparation of customer audits and regulatory inspections;
• Ensure archiving and document management in accordance with internal policies and applicable requirements;
• Collaborate with internal teams to ensure project tracking and compliance;
• Respond to customer and supplier requests regarding regulatory compliance and product qualification;
• Support coordination of exchanges with regulatory bodies, as needed;
• Perform any other tasks related to regulatory affairs.

Qualifications

• Hold a college diploma (DEC) in a field related to regulatory affairs, sciences, quality, administration, or any other relevant education;
• Bachelor's degree in chemistry, biochemistry, engineering, pharmaceutical sciences, or related field (an asset);
• Minimum of 3 years of experience in the pharmaceutical industry or 5 years in the food industry (an asset);
• Excellent English proficiency (understanding and writing);
• Good computer skills;
• Excellent communication skills;
• Autonomy, resourcefulness, and initiative;
• Knowledge of Good Manufacturing Practices (GMP) and pharmaceutical and food regulations (FDA, Health Canada, EMA, ICH, EC);
• Knowledge of FSSC 22000 standard (an asset).

Salary

• Salary determined based on experience and internal salary structure.

Do you think you are the ideal candidate? Apply now or send your resume to carrieresmacco@macco.ca.

Benefits

• Dental Insurance
• Paid Time Off
• Flexible start and end times
• Employee Assistance Program
• Pension Plan
• On-site parking
• Casual Dress Code
• Location: On-site