Regulatory Affairs Project Manager
1 week ago
Knight Therapeutics Inc., headquartered in Montreal, is a pan-American (ex-US) specialty pharmaceutical company helping patients in Canada and 10 countries in Latin America. Knight Therapeutics Inc. is focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America.
Role
Reporting to the Head of Regulatory Affairs Canada/Associate Director, the candidate will be responsible for and support the Associate Director in ensuring timely filing and approval of submissions, maintenance and compliance of files.
Responsibilities
1. Supporting & managing Regulatory submission/review process according to Health Canada requirements & standards and ensuring timely approval of files for drugs and biologics.
2. Managing regulatory activities as assigned to ensure maintenance and compliance of assigned products.
3. Collaborating and coordinating with internal colleagues, corporate partners and consultants for the preparation of regulatory dossiers in line with business priorities and timelines.
4. Ensuring liaison with Health Canada for general regulatory matters and product specific issues.
5. Supporting/leading communications and negotiations with Health Canada during Regulatory reviews.
6. Elaborating regulatory strategies, proactively identifying potential issues and developing/implementing solutions in a timely manner to ensure compliance and support the company regulatory and business plans.
7. Staying abreast of Regulatory environment in Canada (including Health Canada regulations, guidelines), assessing potential impact of upcoming changes on internal processes and ensuring timely communication to internal colleagues and corporate partners.
8. Supporting the Associate Director and/or leading internal discussions on regulatory affairs matters raised internally or by corporate partners.
Qualifications/Job Requirements
- B.Sc or Master’s degree in Life Sciences or relevant scientific field (pharmacy, chemistry, biochemistry or other relevant area)
- Minimum of 7-10 years established experience in Regulatory Affairs
- Strong knowledge of Canadian Regulatory environment, Canadian Food & Drug Regulations, policies and guidelines
- Clinical development, chemistry & manufacturing and scientific knowledge
- Excellent communication skills; written and verbal (bilingualism in English and French is an asset)
- Strong analytical skills with a high-level of attention to detail and commitment to accuracy; able to handle multiple projects at a time
- Excellent interpersonal skills with flexible and adaptable communications capabilities with internal and external partners and stakeholders.
- Proficiency of Microsoft Office Suite
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