Senior Regulatory Affairs Specialist

Company Description

Dyaz Innovate is a software company with its flagship product, DyazRIMS™, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.

Role Description

This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad . The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulatory affairs are handled efficiently.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
• 5+ years of experience in regulatory affairs with a focus on eCTD and CTD submissions for both regulated and non-regulated countries.
• Hands-on experience with eCTD submission software.
• Experience with submission systems and document management processes.
• Experience with Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements.
• Proficiency in Regulatory Affairs and Regulatory Submissions.
• Strong understanding of global regulatory standards and procedures.
• Excellent attention to detail and organizational skills.
• Strong communication skills, both verbal and written.
• Ability to work collaboratively in an on-site setting.
• Problem-solving skills and the ability to troubleshoot technical issues related to client's eCTD submissions.

Key Responsibilities

Skills Required

Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, Regulatory Compliance, regulatory documentation