Senior Director, Regulatory Affairs and Patient Safety

Senior Director, Regulatory Affairs And Patient Safety

Are you an expert in Regulatory Affairs and Patient Safety? Do you have a passion for ensuring compliance and safeguarding patients? Join us as our new Senior Director, Regulatory Affairs & Patient Safety and lead our efforts in maintaining our license to operate while driving strategic initiatives.

Position Description
As the Senior Director, Regulatory Affairs & Patient Safety, you will oversee the Regulatory Affairs Unit for multiple therapy areas and ensure compliance with Health Canada regulations. Your responsibilities will include:

1. Lead the engagement with Health Canada to support regulatory strategic initiatives and interests.
2. Manage the Patient Safety Unit to meet Canadian regulatory and global Patient Safety requirements, ensuring compliance with Novo Nordisk policies and procedures.
3. Provide strategic direction and solutions to complex regulatory and safety challenges.
4. Lead and develop a high-performing team, ensuring individual development plans and annual goals are in place.
5. Manage budgets, including RA/PS Capacity Costs and Health Canada Filing Fees.

Required Qualifications
To excel in this role, you should have:

1. A university degree (minimum B.Sc.) in a regulated health professional field.
2. At least 5 years of experience working in Pharmacovigilance/Patient Safety, including a minimum of five years as a People Manager.
3. Regulatory Affairs experience with Health Canada’s requirements is a strong asset.
4. Experience managing projects, budgets, and Health Authority Audits.
5. Sound knowledge of Canadian Regulatory Affairs and Pharmacovigilance industry standards, with at least 2 years of working experience in Canada required.

About the department
Regulatory Affairs in Canada is a dynamic and fast-paced environment where we ensure regulatory compliance for new products and product amendments. Our team is responsible for gaining regulatory approval of clinical trial applications, new drugs, devices, and digital health solutions. We work closely with health authorities and policymakers to shape future regulatory frameworks. Located in Canada, our department is a hub of innovation and collaboration, with a team of 17-20 dedicated professionals committed to safeguarding patients and ensuring the safety of our medicines.

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 72,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.

Contact
To complete your application, click on "Apply now", attach your CV and follow the instructions.

Deadline
Please apply before April 25th, 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.