Global Regulatory Specialist
5 days ago
Global Regulatory Affairs-CMC Job Description:
This role is responsible for providing strategic direction to expedite CMC development of the portfolio and technical agenda. This includes supporting global clinical trial, market registration submissions, and post-approval submissions.
Main Responsibilities:
- Oversee the preparation and documentation of specified regulatory submissions.
- Provide regulatory leadership and direction for products listed as primary responsibilities.
- Manage submission timelines, monitor approval status, and communicate change status to interested personnel in a timely manner.
- Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations.
Essential Requirements:
- A Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
- Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
- Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.
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