Regulatory Affairs Specialist
4 days ago
Océan is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements for combination products and medical devices.
Job DescriptionThe successful candidate will have a solid understanding of regulatory requirements for the development and approval of investigational products. They will be responsible for providing strategic guidance to cross-functional project teams, recommending global CMC regulatory strategies, and implementing those strategies. Additionally, they will coordinate the planning and conduct of regulatory agency meetings, interact with regulatory agencies, and support departmental activities related to clinical trial conduct and CMC regulatory submissions.
Key Responsibilities:
- Develop and implement CMC regulatory strategy plans for combination products and medical devices that align with project timelines.
- Implement strategy plans and activities for assigned programs, coordinating as needed with CMC members in Japan, Europe, and the US/Canada.
- Lead RA CMC regulatory activities for global project teams/task forces and provide recommendations on global CMC regulatory strategy.
- Evaluate PM NDA compliance for post-approval changes and US/Canada submissions.
- Bachelor's or Master's degree in a scientific discipline.
- Minimum of 6 years of CMC regulatory experience within the pharmaceutical or biotechnology industry.
- Knowledge of the regulatory framework for Combination Products/Medical Devices in major markets.
- Significant experience with registration of Combination Products/Medical Devices.
Océan is an equal opportunity employer. We are committed to fostering a diverse and inclusive work environment where all employees can thrive.
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