About the Role

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

What You'll Do Here

• 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.

What You Need to Succeed

• 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

Technical Skills:

• Strong computer skills (MS Word, Excel, Outlook and Power Point).

• Ability to understand and adapt to various information technology (IT) systems.

Language(s) Skills:

• 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.

Other Requirements:

• 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.

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Senior Regulatory Affairs Associate including, but not limited to, for the following reasons:

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

• The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.

• The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance &Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Review 

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