Regulatory Affairs Manager
2 weeks ago
Role Overview:
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.
- Manage internal databases for product portfolios.
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.
- Strong submissions experience.
- 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.
- Development project management.
- 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.
Travel:
- on an occasional basis.
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