3 months ago
Job title: (Senior) Regulatory Affairs Manager - Rare Disease/Gene Therapy - Home Based
A Rare Disease/Gene therapy business in the UK are seeking a Home Based (Senior) Regulator Affairs Manager. This role will focus on the UK/IE markets and the upcoming withdrawal from the EU markets. Alongside the maintenance of a recently launched product, this role will also support the launch of further products over the coming years. The ideal candidate will have experience within Rare Disease/Gene Therapy and a strong background in the UK/IE and EU markets.
- Act as regulatory submission lead for high quality UK pre- and post-MA submissions in accordance with the Global and European regulatory strategy.
- Participate in regulatory intelligence activities; monitor and inform on regulatory guidelines and trends in Europe with a focus on the UK relationship with the European Union
- Drive the implementation of regulatory guidance in the UK after the end of the withdrawal agreement transition period.
- Lead the creation and maintenance of local regulatory deliverables, including creation of national prescribing information, review and approval of educational materials, reviewing local artwork, input and review of promotional and non-promotional materials.
- Prepare and review sections of regulatory submissions to optimise product development (e.g. Orphan Drug, Paediatric Investigation Plans, scientific advice etc.).
- Develop and maintain SOPs and work instructions (WIs)
- Minimum 5 years of regulatory experience in a biotech or pharmaceutical company preferably including biologics/ATMPs
- In-depth knowledge of current regulations, guidelines - specifically UK/IE
- Experience in rare diseases and/or cell and gene therapies and/or innovative biologics products would be advantageous
- Prior experience in leading a Brexit readiness project would be ideal
Salary and benefits:
A highly competitive salary, annual bonus, healthcare, and pension are on offer
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org