Regulatory Affairs Associate

Mississauga - Canada

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams functions and even the globe.

Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind providing space where teams can come together to strategize brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people the planet and our business are interconnected which is why were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.

Introduction to role:

The Regulatory Affairs Associate assists other members of Regulatory Affairs Management (RAA) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards. This role is crucial in ensuring compliance and supporting the regulatory processes that enable our innovative treatments to reach patients.

Accountabilities:

- Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements

- Working with setting up submissions in Electronic Regulatory Vault (ERV)

- Planning preparing and executing simple submissions and assisting with the preparation and planning of regulatory dispatches

- Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees receipt of incoming FDA correspondence ordering EudraCT number EudraLink support use of HA Portals

- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples Certificates of Pharmaceutical Product Legal documentation e.g. Letters of Authorization Powers of Attorney Translations of regulatory documentation

- Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser

- Provide coaching mentoring and knowledge sharing within the RPM skill group

- Contribute to process improvement

Essential Skills/Experience:

- Relevant qualification and/or experience in science administration or IT

- 1-6 Years Relevant experience from biopharmaceutical industry or other relevant experience

- Proficient verbal and written English

- Project Management skills

- Experience in document management and tracking databases

- Good written and verbal communication skills

- Cultural awareness

- Proficiency with common document management tools

- Ability to work independently and as part of a team

- Continuous Improvement and knowledge sharing focused

Desirable Skills/Experience:

- Some regulatory/medical/technical experience

- Knowledge of AZ business and processes

- Some knowledge of AZ submission compilation publishing and approval processes standards systems and tools

Great People want to Work with us! Find out why:

GTAA Top Employer Award for 10 years

Top 100 Employers Award

Canadas Most Admired Corporate Culture

Learn more about working with us in Canada

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Are you interested in working at AZ apply today!

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

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Annual base salary for this position ranges from 75752.00 to 99424.50.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational some cases offers outside the range may also be considered to address unique circumstances.

In addition our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

Required Experience: