Regulatory Affairs Associate

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
The Regulatory Affairs Associate is responsible for preparing and submitting clinical trial applications with Health Canada's TPD, NHPD, and BGTD.

What You'll Do Here

• Preparing, reviewing and submitting CTAs for small molecules, biologics and natural health products to Health Canada's Directorates (TPD, BGTD, NHPD);

• Company contact and regulatory liaison with Health Canada;

• Analyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory body;

• Oversight and/or preparation of all responses to all Health Canada clarifications requests;

• Performs the needed follow-ups to insure that the regulatory requirements needed to start a study are met;

• Maintenance of submission (CTA-A, notification, cancellation);

• Responsible for assigned study submissions to the IRB, including interactions, answering to clarifications when needed, and ensuring IRB requirements are met prior to protocol implementation;

• Preparing and submitting exemption application for controlled substances;

• Maintains a database for regulatory submissions and related questions;

• Responsible for submission/maintenance of annual clinical documents to IRB;

• May provide regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements and regulatory documentation (such as CTD/NeeS/eCTD format requirements);

• May participates to drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND, pre-CTA);

• May communicates with Health Canada to insure the feasibility and filling requirements of clinic trials requests on the regulatory level;

• Maintain current awareness on regulatory guidelines (such as Health Canada's TPD, NHPD, and BGTD, FDA) and ensure processes are adjusted as necessary;

• Undertake continuous learning and development on regulations through self-training, workshops and conferences;

• Present details of workshops/courses attended or new knowledge acquired;

• Prioritize own work and manage project schedule to meet delivery deadlines;

• Represents Algorithme Pharma in scientific meetings/exhibitions or business meetings.

What You'll Need to Succeed

• Bachelor's degree in Life Sciences.

• Strong interpersonal skills;

• Good verbal and written communication skills;

• Professional attitude;

• Attention to detail and accuracy;

• Ability to work with a multi-disciplinary team of professionals;

• Understanding of clinical research, drug development process, and applicable regulatory guidelines;

• Good computer skills (Microsoft Word, Excel, and Power Point).

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable steps to avoid imposing the above language requirement other than French. This requirement is essential for the position of Regulatory Affairs Associate, but not limited to, the following reason(s):

• The employee frequently communicates with Altasciences employees across Canada and the United States. As such, English is the primary 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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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!