Regulatory Affairs Specialist
6 hours ago
We are seeking a highly skilled Regulatory Affairs Specialist to lead our Regulatory Publishing team. The ideal candidate will have 6+ years of experience in eCTD Regulatory Publishing and strong knowledge of eCTD process.
Key Responsibilities:
- Liaise with cross-functional teams to ensure compliance with government acts and regulations.
- Oversee the publication of Clinical Study Reports, IND documents, NDA documents, and other regulatory documents.
- Perform sampling QC on tasks completed by junior staff members.
- Develop and maintain thorough understanding of publishing software, tools, processes, and output requirements.
- Maintain accurate records and reports related to regulatory submissions.
Requirements:
- Bachelor's degree or equivalent required.
- Strong technical aptitude and problem-solving abilities.
- Excellent communication and organizational skills.
- Able to work under deadlines and modify work schedules as needed.
- Adaptable and self-motivated individual.
Benefits:
- Competitive salary: $100,000 - $120,000 per annum.
- Opportunities for career growth and professional development.
- Collaborative and dynamic work environment.
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