Specialist, Regulatory Affairs

3 months ago

Boucherville, Canada Sandoz Full time

As a **Specialist, Regulatory Affairs **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:

- Develop scientifically sound regulatory strategies for products in development, in line with regulatory guidance for ANDS/NDS/SANDS/SNDS submissions related to generic and biosimilar products.
- Perform gap assessments of regulatory dossiers (Modules 2 and 3) and ensure that Health Canada regulatory requirements are met.
- Compile high quality product regulatory documents for new submissions/variations for various dosage forms to ensure timely approvals.
- Mentor and assist Associates in understanding new regulatory requirements and further build their regulatory skillset.
- Build strong relationship with Health Authorities, development partners and key stakeholders.

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

- BSc in Pharmacy, Chemistry, Biochemistry, or related field.
- 5-8 years of direct experience pharmaceutical industry and in Canadian regulatory affairs, including successful dossier submissions to Health Canada.
- Very good knowledge of the 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.
- Excellent organizational skills including documentation and records management.
- Very good competency in the knowledge, understanding and interpretation of the submissions of the forms of Health Canada.
- Ability to prioritize multiple tasks, time management, and attention to detail.
- Strong customer focus, negotiation skills, and teamwork.
- Autonomous, very good initiative, oriented towards results and objectives.

**Desirable Requirements**:

- Knowledge of FDA, EMA requirements.
- Experience and/or interest in coaching.
- Experience in projects management.

**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.
- 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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