
Regulatory Affairs Specialist, Aseptic Production
hace 2 días
About the Role
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Qrc Group, Llc. As a specialist in aseptic production, you will be responsible for providing expert guidance and support in navigating the complex regulatory landscape.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA and global standards.
- Prepare and review regulatory submissions, including product applications and facility approvals.
- Conduct risk assessments and provide recommendations for mitigating regulatory risks.
- Maintain knowledge of FDA regulations and industry standards for aseptic processing.
- Collaborate with cross-functional teams to ensure effective implementation of regulatory strategies.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
- 5+ years of regulatory experience within the pharmaceutical or biotechnology industry.
- Proven track record of success in regulatory affairs, including experience with aseptic manufacturing.
- Strong communication and project management skills.
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