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Regulatory Affairs Specialist
2 months ago
**Senior Regulatory Affairs Specialist**
We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Quantum. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and guidelines for our products.
Key Responsibilities:
- Regulatory Oversight: Take ownership of regulatory responsibilities across various product categories, guiding them from ideation to approval and post-market phases.
- Collaboration and Communication: Collaborate across cross-functional teams, including R&D, quality, manufacturing, marketing, and sales, to ensure regulatory compliance and effectively communicate regulatory guidance to internal and external stakeholders.
- Regulatory Compliance: Drive decision-making, navigate ambiguity, and solve regulatory challenges efficiently, ensuring seamless compliance with regulations.
- Product Management: Manage regulatory aspects for diverse product categories, including drugs, medical devices, and cosmetics, and oversee facility registrations for various product types.
- Regulatory Updates: Stay updated on regulatory requirements and provide strategic insights to inform business decisions.
Requirements:
- Education: Bachelor's degree in Regulatory Affairs, Life Sciences, or related fields.
- Experience: 5+ years of regulatory affairs experience in pharmaceutical, OTC, or consumer goods industries.
- Regulatory Knowledge: Profound understanding of Canadian regulations for diverse product categories.
- Problem-Solving Skills: Strong problem-solving skills and ability to thrive in a dynamic environment.
- Language Skills: Bilingualism to understand the documentation for Health Canada and to communicate with the teams in the US and Ontario.
Preferred Skills:
- Remote Work Experience: Ability to work independently and collaboratively in a remote environment.
- Virtual Collaboration Tools: Familiarity with virtual collaboration tools.
Character Traits We Value:
- Problem-Solving Mindset: A problem-solving mindset and strong decision-making abilities.
- Autonomy and Accountability: Autonomy and accountability in work, with a desire for impactful contributions and a strong voice within the organization.
