Senior Regulatory Affairs Executive

An excellent opportunity has arisen for a Senior Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.

Responsibilities:

• Work within Regulatory, providing technical support for new marketing authorisation applications, life cycle management and response documents to Regulatory Authority.
• Review product development reports, analytical data of new development projects and provide technical guidance on robustness/improvements where required to development teams.
• Support Head of RA/Line Manager to design, execute remediation experiments and implement changes to existing methods
• Ensure regulatory compliance of organisation’s product Marketing authorisations keeping track of compendial changes, assessing physicochemical analytical methods, executing method revisions and improvements where appropriate and submit changes to Regulatory Authority in a timely manner.
• Review Module 3 CTD dossier for completeness and correctness of data/documents.
• Author and submit module 3 sections of Regulatory applications.
• Critically review RFI and contribute in submitting response to queries regarding analytical methods/specification/validations.
• Participate and play key role in product technology transfers to contract manufacturing organisations (CMOs to CMOs) and at own manufacturing site in accordance with the product licences and GMP Guidelines.
• Review and technically approve documentation including but not restricted to Protocols, Validation Reports, Specifications, methods,
• Provide technical guidance in the understanding of root causes for out of trend or out of specification results or deviations arising during process validation, source/process changes, stability.
• Provide technical support for change management, investigation CAPA identification and related activities at contract manufacturing sites and the clients site.
• Maintain an awareness changing regulatory, GMP, Quality requirements as needed to support the contract manufacture of current products and the introduction of new products
• Work collaboratively across organization and sites for transfers, method performance and trouble shooting.
• Ensure compliance with company policies, procedures and training expectations.
• Any other task given to you by relevant stakeholder in order for you to be able to perform your role

Required Experience:

• Knowledge of compendial methods, technical method transfers and method validations.
• understanding of ICH, EDQM guidelines.
• able to work with a range of stakeholders, at all levels, both internally and externally.