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 youre a recent college graduate or seeking your next career opportunity its 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 Youll 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

• Bachelors degree in Life Sciences. Masters 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 &TelehealthPrograms

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral BonusProgram

• 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!