Senior Associate Regulatory Affairs

Attaineo; Toronto; On-site; CAD 75,000 - 95,000; Full time

Job summary

A leading pharmaceutical company in Toronto is looking for a Senior Associate in Regulatory Affairs to prepare and manage regulatory submissions for injectable generic products and biosimilars. The ideal candidate must have a University Degree in Science or Life Sciences, a post-graduate certification in Regulatory Affairs, and at least 5 years of experience in drug submissions, particularly with Health Canada. Strong communication skills and knowledge of GMP are essential.

Qualifications

• Minimum 5 years of experience in drug submissions for Canada, preferably with parenteral dosage forms and biosimilars.
• Strong understanding of Health Canada and ICH regulatory guidance.

Responsibilities

• Prepare regulatory submissions for complex injectable generic products.
• Liaise with external partners to ensure regulatory compliance.
• Review and file deficiency responses with Health Canada.
• Build healthy relationships with internal and external stakeholders.

Skills

Regulatory compliance

Regulatory submissions

Communication skills

Knowledge of GMP

Education

University Degree in Science or Life Sciences

Post-graduate certification in Regulatory Affairs

Tools

MS Office

Adobe Acrobat

eCTD publishing tools

Job description

Reporting to the Regulatory Affairs Director, the Senior Associate Regulatory Affairs will prepare regulatory submissions for complex injectable generic products and biosimilars; and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Senior Associate Regulatory Affairs will provide sound regulatory input during product development.

KEY RESPONSIBILITIES :

• Coordinates the assembly, including requesting and / or generating, of documents to support submissions including complex generics and biosimilars (NDS, ANDS, SNDS, SANDS, DINA, etc.) per established business processes and systems
• Liaises with external partners / CMOs to request documents and ensures regulatory compliance is met for the purpose of filing successful submissions
• Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries / deficiency letters.
• Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations
• Communicates effectively with internal departments (Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supply
• Reviews, evaluates, prepares, and files deficiency responses for changes filed with Health Canada in a timely manner within given deadlines
• Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement
• Maintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department

TECHNICAL SKILLS :

Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data

Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner

Knowledge of GMP requirements and QA / QC procedures

Strong understanding of Health Canada and ICH regulatory guidance documents and policies

Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset

Demonstrated understanding of sterile product manufacturing is preferred

QUALIFICATIONS :

University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program

Must have a minimum of 5 years of experience in drug submissions for Canada, preferably with parenteral dosage forms and biosimilars