Regulatory CMC Associate

PUB285697

About this role

We’re hiring a Regulatory CMC Associate for a Multinational Pharmaceutical client for a 1 year contract in Toronto, ON

  • Handle the regulatory CMC dossier preparation and to perform gap analysis review of CTD dossier in the context of license conformance program.
  • Authoring of CMC components for various submissions (e.g., post-approval changes, US annual reports, new license applications, renewals, commitments, response to questions)
  • Assessing Industrial Affairs’ change control pre-requests and requests for Canada, US and Europe and preparing the global regulatory strategy
  • Completing data entry for various activities in the regulatory system (i.e., Veeva Vault)
  • Supporting various internal requests (e.g., Quality deviations and assessments, data verification, license information, lot release questions, etc.)

Requirements

  • Regulatory CMC submission writing experience
  • biologic experience, is required
  • 1+ years’ experience working within regulatory and/or within pharmaceutical environment preferred
  • Bachelor’s degree preferred
  • Candidate to be familiar with the main regulatory agency standards (US FDA, Europe and Canada)
  • Ability to work in a group setting and independently; good teamwork skills
  • Ability to adjust to changing priorities and to manage multiple priorities efficiently
  • Detail oriented
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational skills
  • Goal oriented
  • Ability to project and maintain a professional and positive attitude
  • Experience working with computer software, including Word, Excel, Cloud-based platforms, preferred

Benefits

Why work through Brunel? We start with competitive rates, a comprehensive benefits package and a safe on-boarding process. With our industry insights and recruiter expertise, we are supporting projects and clients worldwide. With Brunel you gain experience and expertise, building on your skills and developing your career further.

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services. Join us today.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB285697

Account manager

Diana Grodowski
Brunel Canada - Toronto
d.grodowski@brunel.net

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