Coordinator, Regulatory Compliance

3 days ago

Montréal, Canada Sandoz Full time

#2 Is the position Sandoz reached on the Canadian generic market in 2020. As part of regulatory team and together with our Commercial Operations, this role is for you if you strive to join the team who will win the #1 spot on the podium.The Regulatory Compliance Coordinator supports the continuous improvement and excellence of our regulatory affairs team. Join us, in our journey to reimagine medicine.
- Your Responsibilities:

- Your responsibilities include, but not limited to:

- Support RCC associates in preparation of regulatory submissions for new submissions and post-approval changes. Support RCC associates with deficiency responses (create response document, Module 1, etc.).- Provide clerical support to the Regulatory Competency Centre by managing, distributing and archiving documents.
- Support RCC associates with eCTD activities, as required.
- Word processing of labelling components and other relevant documents. (e.g. Product Monographs, data tables etc). Prepare and review labelling components as per internal requirements.
- Prepare Safety Product Monograph Updates.

**Minimum requirements**
- What you'll bring to the role:
- CEGEP DEC or equivalent experience, Degree in Sciences an asset
- 1-2 years experience within the pharmaceutical industry
- Excellent oral and written communication skills in English and French.
- Good understanding of regulatory compliance activities.
- Strong attention to detail and ability to work in a team.
- Interpersonal skills, customer focus and negotiation skills.

You’ll receive:
- Why Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Sandoz

**Division**
- SANDOZ

**Business Unit**
- COMMERCIAL OPS NA SZ

**Country**
- Canada

**Work Location**
- Montreal South Shore - Boucherville

**Functional Area**
- Facilities & Administration

**Job Type**
- Full Time

**Employment Type**
- Temporary

**Shift Work**
- No

**Early Talent**
- Yes

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