Regulatory Affairs Specialist - India - Apsida Life Science

Description

Regulatory Affairs Specialist - CMC Variations/Submissions

12 month contract - Immediate start

Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You'll be pivotal in ensuring compliance and efficiency in our regulatory processes.

Key Responsibilities:

• CMC Change Control Assessment: Evaluate and assess regulatory implications of changes within CMC processes.
• Submission Planning: Organize and strategize regulatory submissions, maintaining compliance with both timelines and regulations.
• Submission Coordination: Oversee the writing, review, and approval process of CMC submissions, ensuring quality and accuracy.
• Submission Dispatch: Ensure timely dispatch of all regulatory documents to appropriate bodies.
• Health Authority Correspondence: Manage responses to queries from health authorities, coordinating input from Subject Matter Experts (SMEs).
• Regulatory Triage: Receive and prioritize incoming CMC-related regulatory requests and inquiries.
• Response Coordination: Manage the writing, review, and dispatch of responses to health authorities.
• Ad Hoc Responsibilities: Manage procurement of necessary documents, maintain and update tracking tools like Veeva, and coordinate data remediation and submission planning.

Qualifications:

• Bachelor's or higher degree in a relevant scientific field.
• Proven experience in Regulatory Affairs, with a strong focus on CMC.
• Deep understanding of regulatory submission processes and guidelines.
• Excellent organizational, communication, and project management skills.
• Ability to work independently and collaboratively in a dynamic environment.