Bilingual Regulatory Affairs Specialist

Altis Recruitment is seeking a detail-oriented and proactive Bilingual Regulatory Affairs Specialist to join our client, a boutique pharmaceutical company. In this role, you will oversee and ensure adherence to clinical study regulations as outlined by pharmaceutical sponsors, regulatory authorities, ethics review boards, and other stakeholders.

You will play a key role in the start-up phase of studies, coordinating IRB submissions, maintaining compliance, and updating manuals and protocols as needed. The ideal candidate will possess a strong background in clinical research, regulatory affairs, and health and safety, along with the ability to communicate effectively with sponsors and Clinical Research Organizations.

Roles and Responsibilities

• Regulatory Compliance: Ensure all clinical studies comply with applicable regulations and guidelines as set by pharmaceutical companies, regulatory bodies, ethics review boards, and other stakeholders.

• Study Initiation & Start-Up: Lead the start-up phase of clinical studies, managing necessary approvals and overseeing compliance with regulatory standards.

• IRB Submissions: Coordinate all Institutional Review Board (IRB) submissions to maintain adherence to regulatory requirements.

• Documentation Management: Update study manuals, protocols, and other relevant documentation as required to align with regulatory changes and study needs.

• Sponsor & CRO Communication: Act as the primary point of contact for communication with study sponsors and CROs to ensure alignment and address any regulatory queries or issues.

• Regulatory Awareness: Stay current on regulatory updates and best practices, maintaining expertise on FDA, Health Canada, and other international regulatory requirements.

• Health and Safety Compliance: Conduct all work in accordance with the Occupational Health and Safety Act and related company policies and procedures.
  
  

Qualifications and Skills

• Minimum of 2 years in a medical, clinical, or research environment, with a focus on regulatory compliance or clinical research.
• Bilingual in both official languages (English & French, written and oral).
• Demonstrated ability to ensure accuracy and thoroughness in regulatory submissions and documentation, with strong attention to detail.
• Capable of articulating regulatory requirements, negotiating with regulatory bodies, and effectively communicating compliance strategies with diverse stakeholders.
• Skilled in evaluating complex data, identifying regulatory trends (FDA, Health Canada), and analyzing scientific and technical information to support compliance and submission strategies.

Education

• Post-secondary degree or diploma in health, law, science, management, or a related field, or an equivalent combination of education, training, and experience.

Benefits

• 3 weeks' vacation + holiday closure 
• Personal days, 10 stat holidays off and sick days. 
• Comprehensive benefits plan (health, dental & vision) 
• RRSP Matching up to 3% after 3 months