Regulatory Affairs Project Lead
4 weeks ago
Knight Therapeutics Inc., a leading pan-American specialty pharmaceutical company, is seeking a highly skilled Regulatory Affairs Project Manager to support its business growth in Canada and 10 countries in Latin America.
As a key member of the Regulatory Affairs team, you will be responsible for ensuring timely filing and approval of submissions, maintenance and compliance of files, and collaborating with internal colleagues, corporate partners, and consultants to prepare regulatory dossiers in line with business priorities and timelines.
Key Responsibilities:
- Support and manage regulatory submission/review processes according to Health Canada requirements and standards.
- Manage regulatory activities to ensure maintenance and compliance of assigned products.
- Collaborate and coordinate with internal colleagues, corporate partners, and consultants to prepare regulatory dossiers.
- Ensure liaison with Health Canada for general regulatory matters and product-specific issues.
- Support/lead communications and negotiations with Health Canada during regulatory reviews.
- Develop and implement regulatory strategies to ensure compliance and support business plans.
- Stay up-to-date with regulatory environment in Canada and assess potential impact of upcoming changes on internal processes.
- Support internal discussions on regulatory affairs matters.
Requirements:
- Bachelor's or Master's degree in Life Sciences or relevant scientific field.
- Minimum 7-10 years of experience in Regulatory Affairs.
- Strong knowledge of Canadian Regulatory environment, Canadian Food & Drug Regulations, policies, and guidelines.
- Clinical development, chemistry, and manufacturing knowledge.
- Excellent communication and analytical skills.
- Proficiency in Microsoft Office Suite.
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