| || 227420BR |
| || Associate, Development Center & Regulatory maintenance |
| || SANDOZ |
| || Product Dev SZ |
| || Canada |
| || Montreal South Shore – Boucherville |
| || Sandoz Canada |
| || Research & Development |
| || Full Time |
| || Regular |
| || Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country. Our vision: to become the main provider of high quality, affordable medicines and help secure long-term access to healthcare for people around the world. If you are results oriented and recognized for your leadership, expertise, commitment to quality and customers, come join our team!
Summary of tasks:
As per established timelines, prepare and submit regulatory dossiers (submissions and deficiency letters) having the quality necessary to meet regulatory requirements in order to permit timely approvals by regulatory agencies.
Participate in the definition of regulatory strategies.
Prepare, review and manage modules as well as supporting documentation for regulatory submissions
Prepare, review and manage responses to health authority questions.
Participate in the development of regulatory strategies and ensures that all regulatory requirements for the respective markets are met
Negotiate submission requirements with respective teams and/or authorities
Identify potential regulatory issues and provide solutions.
Provide regulatory guidance to project teams as needed.
Support for KPI reporting.
Maintains regulatory databases.
| || Bachelor’s degree in Chemistry, Biochemistry, Pharmacology or other relevant disciplines;
1 to 3 years pharmaceutical CMC regulatory experience;
Strong knowledge of Canadian regulations and ability to interpret and apply policy;
Strong project management and organization skills;
Demonstrated ability to work in a multi-disciplinary team;
Fluent in English and French (spoken & written);
Good knowledge of Microsoft Office Suite.
At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.
Only candidates selected for an interview will be contacted.