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The Regulatory Affairs Manager role at Emporium Human Capital is a critical position that requires a seasoned professional to lead the regulatory team in providing exceptional services to various departments within the organization. This individual will be responsible for managing work streams, reporting on assigned portfolios, and ensuring compliance with relevant laws and regulations.
The ideal candidate will have a strong background in pharmacy or a related field, with a minimum of 5 years of experience in regulatory affairs. They must possess excellent project management skills, sound judgment, and the ability to prioritize tasks effectively.
This role involves coordinating and submitting new product applications to regulatory authorities, reviewing submissions to ensure accuracy and comprehensiveness, and developing regulatory strategies and implementation plans. The successful candidate will also be responsible for maintaining effective relationships with regulatory authorities, internal stakeholders, and external partners.
Key Responsibilities- Manage work streams and report on assigned portfolios
- Assist with internal product queries from various departments
- Coordinate and submit new product applications to regulatory authorities
- Review regulatory agency submissions to ensure accuracy and comprehensiveness
- Develop regulatory strategies and implementation plans