Regulatory Operations Associate

Fresenius Kabi Canada - Toronto, ON (il y a 6 mois)

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Who we are:
Caring for Life. Make a difference. Be the difference.

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.

Fresenius Kabi Canada is currently seeking a Regulatory Operations Associate to join our team!

The Impact You will Make:
The Regulatory Operations Associate is primarily responsible for the compilation, publishing, and validation of electronic regulatory submissions, including New Drug Submissions (NDS’s), Abbreviated New Drug Submissions (ANDS), Drug Identification Number Submissions, Notifiable Changes, and medical device applications and amendments. The Associate is also responsible for Regulatory Information Management activities such as updating and maintaining the RIMS database and the monthly regulatory reports.

The incumbent ensures that the final electronic submissions are in compliance with Health Canada and ICH eCTD standards, and the Fresenius Global Standard Operating Procedures (SOPs).

What You’ll Bring

  • Knowledge & Experience. You possess a Bachelor’s degree in science and have a pharmaceutical or biopharmaceutical experience within regulatory affairs.
  • Technical experience. You have strong computer skills in Electronic Document Management System, MS Office, Adobe Acrobat. Experience with EXTEDO eCTD Manager is a strong asset. You have experience with electronic regulatory transactions via the CESG. You have knowledge of the product life-cycle, and contents/formatting of regulatory submissions.
  • Analytics & Project Management. Your critical thinking and decision-making skills are above average, and you demonstrate excellent analytical skills and a high-level attention to detail. You can effectively analyze data, possess strong investigative skills, and have strong interpretation and operation skills. You have the ability to manage several complex projects in parallel and quickly adapt to changing priorities. Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices
  • Communication & Presentation. You are a skilled leader and able to effectively communicate both in writing and verbally, to collaborate with all levels, both internally and externally. You have a strong business acumen and are able to manage projects while leading change efforts.
  • Attitude & Passion. You are self-motivated individual with initiative and able to work productively with minimal supervision. You have proven ability to adhere to standards and procedures, and to maintain continuous confidentiality.
What We’ll Bring

  • Exposure. The hands-on experience and exposure to a global organization, combined with the mentorship of a dynamic and knowledgeable Regulatory Affairs team. The opportunity to work on a specialized sterile injectable portfolio of specialty brand products , generic intravenous drugs, and biosimilars; in addition to transfusion and infusion medical devices
  • Positive Collaborative Environment. A welcoming, fun and energetic team environment that encourages open communication and collaboration. Our culture encourages our employees to hone current skills and build new capabilities, while discovering their genius.
  • Impact. You will be an integral part of the projects and initiatives that will contribute to the strategic planning and growth of the organization. The opportunity to broaden your scope or current skillset with a business that combines product and service.