What are the responsibilities and job description for the Regulatory cmc specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities :
Supports batch release by following submission and approval to ensure the product regulatory compliance on his / her sites(s).
Response to agency lot release questions.
Ensures that the CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities.
Prepares and provides Regulatory documentation required for site registration and renewal activities CMC Documentation Management.
Writes and approves CMC regulatory documents / dossiers to be dispatched to regulatory affairs functions for submissions.
Coordinates CMC writing performed by another entity (internal or external).
Optimizes the content of CMC dossiers to facilitate the management of future changes.
Prepares response to questions from Health Authorities with contribution of site experts.
May contribute to Critical Process Analysis and Testing Strategies.
Requirements :
Ability to resolve strategic technical and regulatory issues.
Should demonstrate initiative, analytical thinking and work independently.
Experience working with a Health Authority is helpful but not essential.
Knowledge of global regulations / guidelines, key Health Authority / Industry Guidance and trends are helpful.
Bachelor's degree in Biological Sciences with 3 years Regulatory Affairs experience OR Master's degree in Regulatory Affairs / Quality Assurance or an appropriate combination of other relevant industry experience e.
g., Quality and / or Manufacturing.
Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations / guidelines.
Strong authoring skills of CMC documentation and Health Authority responses.
Last updated : 2024-11-19
