The Role:Is responsible for maintaining current regulatory documentation for the site processes responding to changing business and regulatory agency requirements. The role provides expert regulatory...
Is responsible for maintaining current regulatory documentation for the site processes responding to changing business and regulatory agency requirements. The role provides expert regulatory knowledge to the site through the direction of multidisciplinary teams. This roles is responsible for the QMS implementation process across site.
- Lead the maintenance of site compliance to licences/ pharmacopoeias and worldwide regulatory requirements.
- Manage the preparation and review of submissions for variations/supplements for all the site's products.
- Liaise with Global Post Regulatory Affairs and North America Post Regulatory Affairs to review questions from global regulators and provide and agree official responses.
- Provide expert regulatory advice critical to the development and implementation of strategic projects and for ongoing production batch destination.
- Approve Technical Terms of Supply and Technical Agreements with global markets and 3rd parties.
- Lead the setting and registration of appropriate specifications for all site products.
- Provide regulatory support for Level 3 and 4 audits.
- Life Sciences degree qualified
- Comprehensive knowledge of worldwide regulatory requirements and current standards and formats
- Comprehensive knowledge of operations in areas of expertise, e.g. Steriles, packaging, manufacturing,
- Understanding of mechanisms involved in Pharmacopoeial monographs/test methods and General Notices
- Awareness of the regulatory requirements of change and impact on business processes of delays
- Good knowledge & understanding of the QMS and change control system in particular.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.