Regulatory Affairs Director EU Development

UK, London
Dec 06, 2017
Dec 14, 2017
Contract Type
Full Time
An exceptional opportunity has opened up in West London. This would be a strategic development regulatory role focused on taking early development biological/biosimilar products through from PoC to regulatory filing with the EMA. The company have a number of marketing authorisations and have large backing, but the organisation is still within its infancy, so you will have maximum opportunity to impact the development pipeline and lead drug filings for key assets. You will have significant biotech drug development expertise from prior experience within biotech, Pharma or CRO environments and have participated in MAA filings/CHMP review, scientific advice, PIPs, CTA etc as well as produced high quality CTD. This is a position for a high calibre individual looking to progress their career at a pivotal time; on offer is a unique opportunity within the biotech sphere.

Job Responsibilities:

* Involves in establishing and executing regulatory non-clinical and clinical development strategies and plans for initial marketing authorization and product life cycle management
* Provide non-clinical and clinical regulatory intelligence and strategic insight to the team and relevant functions
* Provides support on identifying opportunities, risks and mitigations from reg. Dev. perspectives
* Provide authoring and reviewing regulatory core dossier including CTD and responses to regulatory authorities in relevant to non-clinical and clinical field in close collaboration with relevant functions
* Works closely with relevant functional teams to provide strategic regulatory guidance in non-clinical and clinical fields.
* Establishes and maintains good working relationship with non-clinical and clinical expert regulatory groups in regulatory agencies and industry
* Provides value-added support to improve team standard operation procedures by authoring new SOP or editing existing SOP
* Supervise and trains junior level employees
* Provides support to relevant functions including global regulatory affairs for non-clinical and clinical issues and questions, and ensures non-clinical and clinical requirements are addressed
* Provides support to global regulatory affairs on reviewing briefing document and attending the agency meeting to provide non-clinical and clinical expertise
* Provides support to global regulatory affairs on reviewing IMPD and providing strategic guidance from non-clinical and clinical perspectives in responding to agency's questions.
* Provides assessment of change control/subsequent variation strategy

To Apply:

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