[Hiring] Senior Regulatory Affairs Associate @CareAbout

Role Description

The Senior Regulatory Affairs Associate is responsible for preparing regulatory agency submissions.

• Prepare, review and submit CTAs and INDs for small drug molecules, biologics, natural health products and combo drug-medical devices to regulatory agencies.
• Prepare and submit Pre-CTA and Pre-IND consultation meeting with regulatory agencies.
• Provide review and gap analysis of regulatory documents.
• Write, prepare and review the Quality Overall Summary (QOS).
• Liaise with Health Canada/FDA and ensure expectations are met.
• Analyze the information provided by the sponsor and prepare a complete file showing the relevant information to the regulatory body.
• Prepare and review all responses to all Health Canada and FDA information requests.
• Perform the follow-ups needed to ensure that the regulatory requirements to start a study are met.
• Maintain regulatory submissions (amendments, notifications, annual reports, meeting requests, briefing documents, designation requests, trial closure).
• Prepare, review and submit exemption application for controlled substances to the Office of Controlled Substances (OCS).
• Maintain current awareness on regulatory guidelines (such as Health Canada, FDA and ICH) and ensure processes are adjusted as necessary.
• Maintain a database for regulatory submissions and related questions.
• Provide critical regulatory review of key regulatory documentation and support the company-wide regulatory intelligence process.
• May participate under supervision on the feasibility and assessment of the regulatory strategy.
• Communicate and consult with regulatory agencies.
• Undertake continuous learning and development on regulations through self-training, workshops and conferences.
• Share with the team details of workshops/courses attended or new knowledge acquired.
• Prioritize own work and manage project schedule to meet delivery deadlines.

Qualifications

• Bachelor’s degree in Life Sciences. Master’s degree preferred.
• Minimum of 2 years of related experience, in a regulatory field preferred.
• RACS certification a strong benefit.

Requirements

• Strong computer skills (MS Word, Excel, Outlook and Power Point).
• Ability to understand and adapt to various information technology (IT) systems.
• Ability to read and interpret technical documents and industry specific manuals.
• Ability to write advanced reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
• Excellent verbal and written communication skills.
• Critical thinking skills and ability to acquire and apply knowledge quickly.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Thorough understanding of clinical research, drug development process and applicable regulatory guidance.
• Fluency in English is an essential requirement for the position.

Benefits

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Review