Regulatory Affairs Manager

3 weeks ago

Toronto ON, Canada EightSix Network Inc Full time

This position entails overseeing project management within Regulatory Affairs for both emerging and established products.

Responsibilities:

- Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles.

- Develop and implement filing strategies, evaluating scientific and clinical data as needed.

- Arrange and manage meetings with relevant regulatory authorities.

- Ensure the timely preparation of regulatory submissions adhering to internal strategies and Health Authority Regulations.

- Participate in cross-functional meetings, offering expertise on product strategies.

- Maintain ongoing compliance for marketed products, including updates to product monographs and labels.

- Review and approve promotional and non-promotional material in accordance with regulatory standards.

Requirements:

- Change leadership skills, with the ability to adapt and prioritize effectively.

- Strong strategic and analytical thinking abilities.

- Capable of managing and influencing key stakeholders.

- Openness to innovation and new processes.

- Ability to work independently and collaboratively.

- Bachelor's degree in a health-related field.

- 5+ years of Regulatory Affairs experience, demonstrating success in regulatory environments.

- Proficiency in current regulatory regulations and guidelines.

- Cross-functional experience.

Language Skills:

- Proficiency in English (written and spoken). Other languages would also be a plus, though not mandatory.

Computer Skills:

- Proficiency in MS Outlook, PowerPoint, Word, Excel, and Adobe Acrobat.

- Familiarity with Veeva Vault database is preferred.

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