Vice President of Regulatory Affairs - Biotech

This is a new appointment for a Vice President of Regulatory Affairs 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. This includes clinical, CMC and Regulatory Operations. As the company grows the Vice President of Regulatory Affairs will be responsible for building an effective Regulatory Affairs function that continues to meet the needs of the company.

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

·        Proactively identifying risks to the Regulatory plans and developing ways to mitigate risks

·        Taking responsibility for training of staff in Regulatory matters as required 

·        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