Regulatory Affairs Senior Director / Director - Gene Therapy
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|Area||North London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 90,000 ~ 120,000 Annual Rate|
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.
· 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