![Achieva Group Limited](https://media.trabajo.org/img/noimg.jpg)
Compliance Manager/Senior Manager
1 week ago
Gather, consolidate, analyse documentation and submit regulatory filings.
Coordinate and prepare written responses to requests for information from regulatory authorities.
Monitor status of regulatory applications.
Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction.Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.
Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products.
Supervise assigned team members with respect to management and training.Shall participate in resource planning and recruitment procedure.
Ensure compliance with company policies, procedures and training expectations.
understanding of GMP, Quality and Regulatory requirements.
Maintaining an awareness changing regulatory requirements.
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