Jul 21, 2022

Job Description

700 generic products and 6 biosimilars covering 280 molecules and medicinal ingredients spanning multiple therapeutic areas represents the Sandoz portfolio of products in Canada. The Specialist Regulatory Affairs supports the increasing expansion of our product portfolio, and continuous improvement and compliance of our marketed products. Join us, in our journey to reimagine medicine.

This position offers the possibility of working virtually 80% of the time, so 20% in person at the head office.

Your responsibilities include, but not limited to:
• Provide regulatory guidance for new submissions (development of regulatory strategies, negotiate submission requirements with teams and Health Canada)
• Prepare regulatory submissions for new submissions and for the lifecycle management products, such as biosimilars (i.e. ANDS, NDS, SNDS, NCs, YBPRs, Annuals, PSUR and RMP)
• Performs gap assessments of regulatory dossiers (Modules 2 and 3) and ensures that Health Canada regulatory requirements are met
• Collect regional requirements and ensures templates for regulatory requirements in Canada are maintained current and any new requirements are communicated to all relevant stakeholders across the organization in a timely manner
• Represent the team in project update meetings with Global and Local teams
• As Specialist, mentor and assist Associates in understanding new regulatory requirements and further build their regulatory skillset

Diversity & Inclusion / EEO

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:
• BSc (Pharmacy, Chemistry, Biochemistry or related) or equivalent experience and 5-8 years’ experience within regulatory field
• Experience preparing regulatory submissions for new submissions and for the lifecycle management of generic products and biosimilars (i.e. ANDS, NDS, SNDS, NCs, YBPRs, Annuals, PSUR and RMP)
• Excellent oral and written communication skills in English and French
• Very strong organizational skills and strong attention to detail.
• Interpersonal skills, customer focus and negotiation skills
• Excellent analytical thinking, attention to accuracy and respect of deadlines.

You’ll receive:
Competitive salary, sales incentive, pension scheme, health insurance, flexible working arrangements, employee recognition scheme. Find out more about Sandoz Canada: https://www.sandoz.ca/

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!
Montreal South Shore – Boucherville
Research & Development
Full Time
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Specialist, Regulatory Affairs (temp. 18 months) Poss. 80% virtual

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