Associate, Regulatory Competency Center

3 weeks 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 wish to join the team who will win the #1 spot on the podium In this role you are responsible to prepare regulatory administrative dossiers (Module 1) and submit dossiers by the pre-established deadlines and of a quality to meet the regulatory requirements to permit timely approvals by the Canadian Competent Authorities.
- Your responsibilities include, but not limited to:
- Prepares, reviews and manages regulatory submissions and act as Sandoz point of contact with Health Canada for assigned projects (i.e. ANDS, NDS, SANDS, SNDS, NC, PSUR, RMP, YBPR, etc.).
- Preforms CMC gap assessments and follow up on assigned projects to ensure compliance with regulatory requirements.
- Liaises and negotiates submission requirements/timelines with Health Canada. Updates stakeholders of submission progress/completions.
- Prepares and reviews the content of responses to Health Canada requests to ensure they are complete and in accordance with requirements.
- Supports the launch team to ensure target launch dates are met.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**
- What you'll bring to the role:
- Bachelor in one of Chemistry, Biochemistry, Pharmacy, Microbiology etc.
- 3-5 years’ experience in regulatory affairs.
- Good regulatory knowledge of Canadian regulatory requirements and guidelines for generic products, assessment skills. Good knowledge of EU and US regulatory requirements. Experience with biosimilar products is an asset.
- Good communication and good negotiation skills.
- Good teamwork and collaboration skills.
- Strong attention to detail and excellent sense of time management.
- Advanced knowledge of Office (Word, Excel, PowerPoint), Outlook and SharePoint.
- English and French: spoken and written.

You’ll receive:
- Why consider Sandoz?
- Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we
- continue to pioneer access in an ever-more digital and global world?
- The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
- Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
- Imagine what you could do at Sandoz

**Division**
- SANDOZ

**Business Unit**
- COMMERCIAL OPS NA SZ

**Country**
- Canada

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

**Company/Legal Entity**
- Sandoz Canada

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Temporary

**Shift Work**
- No

**Early Talent**
- No

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