Regulatory Affairs Intern

**Make your mark for patients**

We are looking for a **Regulatory Affairs Intern**to join us in our **Regulatory Affairs Team** based out of our **Oakville, ON** office (hybrid, 2 days per week onsite).

**About the role**
The primary responsibility of this position is to assist in the compilation and maintenance of regulatory submission documentation to Health Canada for UCB Canada pharmaceutical and biologic marketed and investigational products.

**What you’ll do**
- Assist with the assembly of regulatory submissions for NDS, SNDS, NC and Level III submissions to Health Canada’s PDD and BRDD.
- Assist in the preparation of complete responses to questions from Health Canada submission reviewers and screeners, within Health Canada guidelines and prescribed timelines.
- Assist in the management and tracking of regulatory eCTD submission documentation within global Electronic Document Management Systems.
- Ensure that product labeling is accurate, regulatory compliant, and maintained/updated as required.
- Maintain post-market product compliance for assigned products, including assessment of proposed CMC changes.
- Working with Data Transparency team, assist in the preparation of PRCI submissions.
- Initiate and contribute to local process improvements which have an impact on the Regulatory Affairs department.
- Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations and evolving regulatory guidance.
- Other regulatory duties as required to ensure ongoing compliance with Canadian regulatory requirements and the achievement of applicable goals and objectives.

**Interested? For this role we’re looking for the following education, experience and skills**
- Bachelor’s degree
- Recent graduate with completed Regulatory Affairs certificate preferred
- Understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
- Knowledge and understanding of regulatory submission content and format including the drug development process.
- Well-developed ability to understand and summarize scientific data for the purpose of determining regulatory drug submission requirements.
- Solutions-oriented and learning mindset with the ability to thrive in a fast-paced and dynamic environment
- Proven ability to work well both independently and in a cross-functional team setting
- Excellent interpersonal and communication skills

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.