About Us

Since 2001, Regulatory Solutions Inc. (RSI) is a pharmaceutical regulatory affairs and quality compliance consulting firm with a proven track record spanning over two decades.

Our expertise lies in securing Canadian regulatory approvals for prescription drugs, natural health products, and medical devices.

At RSI, we cultivate a dynamic work culture that encourages innovation and high performance in a fun and fast-paced environment.

RSI is constantly looking for great people to contribute to our growing business. We believe in empowering our employees by giving them the freedom to raise new ideas and encourage decision making in an environment that fosters growth and development.

About the Role

The Regulatory Affairs Specialist, CMC is responsible for ensuring that RSI and their clients comply with the Chemistry, Manufacturing, and Control (CMC) regulatory submission requirements in accordance with Health Canada regulations and guidance.

This position is responsible for the preparation and review of CMC information for new and existing products across multiple dosage forms for prescription and OTC products, including, oral, injectables, and topical drug products.

The candidate will be self-motivated, energetic and a resourceful individual who will work closely with the internal team and external stakeholders to support the regulatory activities related to CMC compliance.

Specific Responsibilities

• Assist and collaborate in the planning, reviewing and preparation of the regulatory CMC submissions, renewals / annual reports, notifiable changes and supplements to Health Canada
• Prepare Product Monograph updates to Health Canada
• Review and prepare the Quality Overall Summary (QOS) to support NDSs, ANDSs, SNDSs, SANDSs, DINA, NCs and CTAs
• Review and provide CMC and regulatory aspects of submission
• Assess post-approval changes and assist in providing regulatory filing strategies
• Prepare responses to Health Canada requests
• Ensure regulatory compliance with Health Canada regulations
• Support life-cycle management activities for regulatory submissions and post-approval changes
• Liaise with Health Canada and clients on submissions, as applicable

Required Qualifications

• B.Sc. / M.Sc. degree in Biological / Life Sciences / Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry), or related fields.
• A minimum of 3 years of direct Canadian Regulatory Affairs experience
• Hands on experience with preparing regulatory submissions for brand and generic prescription drugs, biosimilars within Canada.
• Experience working with small molecules across various dosage forms (solid oral, injectables, topicals, etc.).
• A strong background in Chemistry and Manufacturing Controls (CMC).
• Experience with eCTD knowledge and application.
• Working knowledge and application of Health Canada regulations , guidelines and policies
• Good technical knowledge of pharmaceutical manufacturing, quality assurance, clinical research and GMP
• Strong analytical skills with the ability to assess scientific data
• Proven adaptability to changing environments and priorities
• Ability to work independently and under pressure
• Ability to forge strong working relationships with internal and external business partners
• Excellent oral skills in English, written and listening communication skills.
• Proven technical writing and critical thinking skills

Desired Qualifications

• A diploma / degree in regulatory affairs is an asset.
• Canadian non-prescription drug, medical device, natural health products, and cosmetics experience.
• Regulatory certifications or memberships in industry associations.
• Experience with international regulatory affairs.
• Knowledge of Health Canada's electronic submission formats and tools.
• Proficiency in French language is an asset.
• Multilingual skills for effective communication.

Benefits Offered

• Competitive Benefits Package
• Learning & Development Opportunities

If you meet these qualifications and are interested in joining our team, please submit your resume to [email protected].

At RSI, we value diversity and inclusion and are committed to creating an equitable workplace for all. We appreciate all applicants' interest in this position;

however, only those being considered for an interview will be contacted.

Remuneration is competitive and will be based on qualifications and experience. Please include salary expectations when applying