Regulatory Affairs Specialist
3 weeks ago
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.
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