Associate, Regulatory Affairs, Operations

4 months ago

Boucherville, Canada Sandoz Full time

As an **Associate, Regulatory Affairs, Operations **and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day.

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Prepare and submit Safety Product Monograph Updates or any other labeling update submissions and manage all related authority deficiency questions for a timely approval.
- Ensure compliance of artwork with Health Canada guidelines and regulations.
- Conduct regulatory review and timely approval for all artwork/labelling.
- Monitor Health Canada and other industry websites for changes in guidelines/requirements and practices. Take these upcoming changes into account for the development of artwork for new products.
- Establish and maintain department standards for packaging and labelling documents.
- Coordinate and track Safety Label Changes to ensure compliance with global SOP timelines and process.
- In collaboration with Regulatory Associate or delegate, create labeling for new product submissions and support with labeling portion of authority deficiency requests.
- Support RCC team with deficiency responses for labeling (create response document, Module 1, coordinate artwork update, etc.).

**What you’ll bring to the role**:
**Essential Requirements**:

- Bachelor’s degree in Sciences, Biochemistry, Chemistry, Microbiology, Pharmacology or Pharmacy.
- 2 to 3 years of experience in Regulatory Affairs or Quality.
- Comfortable with MS Office Suite.
- Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
- Ability to manage / coordinate priorities and several projects simultaneously.
- Collaborative and teamwork oriented with also been able to work autonomously.
- Very detailed oriented.

**Desirable Requirements**:

- Minimum of 1 year experience with Module 1.
- Basic knowledge for the preparation/exam for technical modules of regulatory documentation for Canada.
Knowledge of Health Canada guidelines and policies related to product labelling.
- Project management experience.
- Knowledge of Docubridge and/or eCTD and/or TVT

**You’ll receive**:

- A minimum of three weeks’ vacation.
- Paid time off in addition to your annual vacation and statutory holidays.
- Time back between Christmas and New Year’s Day with full pay.
- Group pension plan with substantial employer contributions.
- Generous and flexible group insurance coverage through our private plan.
- Employee and family assistance.
- Hybrid work formula offered.
- Telemedicine services.
- Parental leave - supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation.
- Career enhancement and development, including learning, training and professional recognition opportunities.

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**Join our Sandoz Network**:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool

**#Sandoz**

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