Associate, Regulatory Compliance

2 weeks ago

Montréal, Canada Sandoz Full time

+250 molecules, including 20 of the 25 most important molecules on the market, Sandoz holds one of the most significant product portfolios in Canada. Sandoz is a Novartis Division. You will be responsible to prepare, review and submit changes for products on the market. You will 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. You will participate in the definition of regulatory strategy.
- Your responsibilities:

- Your responsibilities include, but are not limited to:
- Prepare Module 1 for Canadian submissions. Obtain/prepare all supporting documentations required to complete submission (e.g. DMF letters, certifications);
- Prepare labeling for new Canadian submissions.
- Review Modules 2, 3, 4 and 5 provided by DRCs for Canadian format and content and provide RCC comments to DRC;
- Manage deficiency letters, prepare response templates, respond to administrative deficiencies, review technical responses, prepare final compilation of response, confirm timelines;
- Negotiate submission requirements with Health Canada;
Provide Regulatory Support:
- Collect regional requirements for DRC;
- Prepare presentations to outline regulatory strategy and procedures;

**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**
- Bachelor's degree in Biochemistry, Chemistry, Microbiology, Pharmacology or Pharmacy with 3 to 5 years of experience in Regulatory Affairs.
- Preparation of regulatory documentation for Canada.
- Basic Knowledge of Canadian regulatory requirements;
- Very good oral and written communication skills in French and English.
- Ability to manage / coordinate several projects simultaneously.
- Very detailed oriented.

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?
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

**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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