Senior Associate in Regulatory Affairs

Your new company!

At Altasciences, we all work in harmony to contribute to the discovery, development, and manufacturing of new medicinal therapies so they can reach people who need them faster. Whatever your role, we all play an important part and you will have a significant impact on the health and well-being of people around the world. In keeping with our values of employee development, customer focus, quality and excellence, respect and integrity, we seek to foster a passionate and collaborative work environment and are looking for talented and enthusiastic people like you to join our growing team! Whether you are a recent university graduate or looking for your next career opportunity, it is time to discover your future at Altasciences.

We are better together and that is how we are Altasciences.

About the position

The Senior Associate in Regulatory Affairs is responsible for preparing the dossiers to be submitted to regulatory authorities.

What you will do here

• Prepare, review, and submit to regulatory authorities the applications for market authorization (CTA) and applications for clinical trial authorization (IND) for small molecule drugs, biological products, natural health products, and drug-device combinations.
• Prepare and organize pre-submission consultations with regulatory authorities for CTA and IND applications.
• Review and analyze the gaps in regulatory documents.
• Write, prepare, and review the overall quality summary (QOS).
• Ensure liaison with Health Canada and the FDA and ensure that expectations are met.
• Analyze the information provided by the sponsor and compile a complete dossier presenting the relevant information to the regulatory body.
• Prepare and review all responses to Health Canada and FDA information requests.
• Perform the necessary follow-ups to ensure that the regulatory requirements for launching a study are met.
• Manage regulatory submissions (modifications, notifications, annual reports, meeting requests, information documents, designation requests, trial closure).
• Prepare, review, and submit deviation requests regarding controlled substances to the Controlled Substances Office (OCS).
• Stay informed of the latest regulatory guidelines (such as those from Health Canada, the FDA, and the ICH) and ensure that processes are adapted if necessary.
• Manage a database related to regulatory submissions and associated questions.
• Conduct an in-depth regulatory review of key regulatory documents and support the company-wide regulatory surveillance process.
• May participate, under supervision, in the feasibility study and evaluation of the regulatory strategy.
• Communicate and consult with regulatory authorities.
• Ensure continuous and ongoing regulation training through self-study, workshops, and conferences.
• Share with the team the details of the workshops or training followed, as well as the new knowledge acquired.
• Prioritize tasks and manage project schedules to meet delivery deadlines.

What you need to succeed

• Bachelor's degree in life sciences. Master's degree preferred.
• At least 2 years of experience in a relevant field, preferably in the regulatory field.
• The RACS certification is a major asset.
• Technical skills:
• Strong computer skills (MS Word, Excel, Outlook, and PowerPoint).
• Ability to understand and adapt to various computer systems.
• Language skills:
• Ability to read and interpret technical documents and sector-specific manuals.
• Ability to write advanced-level reports and letters.
• Ability to effectively communicate with groups of clients or organization employees.
• Other requirements:
• Excellent oral and written communication skills.
• Critical thinking and ability to quickly acquire and apply knowledge.
• Professional attitude and strong interpersonal skills.
• Ability to work effectively within a multidisciplinary team of professionals.
• Customer-focused work approach.
• Flexibility in the tasks assigned and in the learning of new skills.
• Ability to prioritize tasks in the workload.
• In-depth knowledge of clinical research, drug development process, and applicable regulatory guidelines.

Altasciences strives to offer a French-speaking work environment to its employees in Quebec. However, as part of its francization program, the company has taken all reasonable measures to avoid imposing the aforementioned requirement. Proficiency in English is an essential requirement for the position of Senior Associate in Regulatory Affairs, particularly but not limited to, for the following reasons:

• The obligation to write and record in English the study protocols, study plans, and clinical research documents, in accordance with the requirements of the sector's regulatory bodies.
• The employee frequently communicates with Altasciences colleagues across Canada and the United States. As such, English is the main language used for correspondence between the different offices.
• The employee frequently communicates with English-speaking clients located outside the province of Quebec.

What we offer

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

Altasciences' comprehensive benefits package includes

• Health/dental/eye insurance.
• 401(k)/REER with employer contribution.
• Paid vacation and holidays.
• Paid sick and bereavement leave.
• Employee assistance and telehealth programs.

Altasciences' incentive programs include

• Training and development programs.
• Employee referral bonus program.
• Annual performance reviews.
• #LI-AN1
• WE MOVE TOGETHER TO ACHIEVE MAXIMUM IMPACT WHILE OFFERING A PERSONALIZED TOUCH.

Altasciences is an equal opportunity employer and is committed to promoting diversity and inclusion. Our goal is to attract, develop, and retain highly talented employees from diverse backgrounds, which allows us to benefit from a wide variety of experiences and perspectives. All qualified candidates will be considered for employment without regard to age, race, color, religion, belief, sex, sexual orientation, gender identity, national origin, disability, or any other protected status under applicable law. Reasonable accommodations for individuals with disabilities are available upon request. Join us at Altasciences!