About the RoleThe 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 OfferAltasciences 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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