Regulatory Chemistry Project Lead
4 weeks ago
Embark on a rewarding career as a Regulatory Chemistry Project Lead at BioTalent Canada, where you'll play a crucial role in shaping the future of medicine.
About UsWe are an innovative global healthcare company dedicated to improving people's lives through groundbreaking research and development.
Job DescriptionWe are seeking an experienced Regulatory Chemistry Project Lead to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing regulatory strategies, filings, and approvals for marketed and development products.
Your primary focus will be on collaborating with our Global Regulatory Affairs teams and external partners to ensure seamless compliance with local and global regulations.
You will lead the submission process for all CMC aspects of the submission dossier and local regulatory documents, including initial New Drug Submissions, post-Notice of Compliance quality changes submissions, and Yearly Biologic Product Reports.
- Manage regulatory strategies, filings, and approvals for marketed and development products;
- Collaborate with Global Regulatory Affairs teams and external partners to ensure compliance with regulations;
- Lead the submission process for CMC aspects of the submission dossier and local regulatory documents;
In this role, you will have the opportunity to work closely with our cross-functional teams, including Quality Assurance, Quality Control, and Production.
Requirements- 5-10 years of combined experience in the pharmaceutical industry: Regulatory Affairs, Quality Assurance, Quality Control, Production;
- Demonstrated success in a regulatory environment;
- Solid understanding of manufacturing processes and characteristics of various drug dosage forms;
- Able to manage and influence key stakeholders;
The estimated annual salary for this position is $120,000 - $150,000 CAD, depending on qualifications and experience.
As a valued member of our team, you will also enjoy a comprehensive benefits package, including health and wellbeing benefits, high-quality healthcare, prevention and wellness programs, and opportunities for professional growth and development.
We offer a supportive and inclusive work environment that encourages collaboration, innovation, and continuous learning.
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