My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Regional Strategist on an initial 12 Month...
My Client a Global Pharmaceutical Company has opened a new vacancy within there Regulatory team and are looking to recruit a Senior Regulatory Executive- CMC on a 12 Month contract basis to be based at their offices in Hertfordshire or Greater London
This position will be directly responsible for managing CMC post-approval activities for a biopharmaceutical product approved in US, EU, Japan, and ROW markets. Work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and content of the CMC sections of the responses.
Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
Directly manage completion of multiple dossier components to meet project timelines.
Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles.
Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.
Bachelor's degree in life sciences or related scientific discipline.
Extensive experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
Experience in authoring CMC content for regulatory submissions is required, preferably with a regulatory affairs or related function.
Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA).Ability to track multiple dossier components and manage successful completion of components for submissions.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626