Regulatory Affairs Senior Director / Director - Gene Therapy

2019-08-02 16:00:132019-12-18LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 90,000 ~ 120,000 Annual Rate
Job Ref0064I00000twvGFQAY
Job Views713
Description

This is a new appointment for a Regulatory Director / Senior Director working for an inspiring company who are at the forefront of developing life-changing Gene Therapies. With three Gene Therapy products and an exciting pipeline, we are seeking a seasoned professional with a passion for Gene Therapy and making a real difference to patients lives.


Choice of three Locations:

Hertfordshire, UK / Boston, US / New York, US (Flexibility for a combination of office and home-based working)


The appointed candidate will be accountable for all aspects of Regulatory Affairs in all territories in which the company operates.


Responsibilities include:

·        For each product in development the creation, agreement and delivery of a global Regulatory strategy, that is consistent with business objectives.

·        Ensuring preparation of high-quality Regulatory documents including, but not limited to, IMPD/CTA/IND, briefing documents, orphan drug applications, paediatric investigational plans, MAA/BLA and other Regulatory filings

·        Leading and managing Regulatory authority interactions

·        Provide strategic direction and operational Regulatory support to the project teams and other groups within company as required

·        Keep abreast of relevant Regulatory intelligence and ensuring this is communicated, appropriately, across the company.

·        Managing third party providers such as Regulatory service providers and medical writers to ensure business objectives are met

·        Remain up to date on global Regulatory requirements including clinical and CMC aspects.


Education and Previous Regulatory Experience Requirements:

·        Bachelor degree in Life Science - Master or PhD preferred

·        Significant experience in Regulatory Affairs including experience of European and US Regulatory environments from early development, through CTA/IND, to filing of MAA/BLA and maintenance of approvals.

·        Japanese Regulatory Affairs experience would be beneficial.

·        Experience of the development of GTMP (Gene Therapy Medicinal Products) and rare disease products with a strong working knowledge of the Regulatory requirements including knowledge of accelerated and conditional approval routes within FDA and EMA.

·        A proven ability to create and drive an effective clinical Regulatory strategy.

·        Experience of planning and leading meetings with the FDA, the EMA and European national Regulatory authorities


To book a confidential discussion regarding this appointment please email Natalie directly with your details to arrange a call Natalie@linkfieldgroup.com

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