Senior 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 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
#LI-AN1
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!