Interim Regulatory Affairs Director : EMEA
Our Client is an ambitious speciality pharma company, publicly quoted and with revenues in excess of $1 billion. Global headquarters are in the US, with European operations managed via a base in the UK.The company currently has a portfolio of pioneering and innovative products that are available in over 40 countries around the world and which help treat patients for a condition that is recognised as one of growing public health concern.
Other key products are in development and are expected to contribute significantly to the company’s future global growth in the coming years.
The need has emerged for an Interim Regulatory Affairs Director : EMEA who will be responsible for leading all regulatory affairs activities across Europe / EU and Middle-East Africa.
This is a senior level role, reporting directly to the Senior VP Global Regulatory Affairs in the US.
Key responsibilities include:-
- Leading a team of regulatory professionals across Europe
- Liaising directly with EMEA Regulatory Authorities
- Defining global regulatory strategies and submissions in support of new and existing marketing authorizations.
- Regulatory compliance
This interim assignment is expected initially to be of 6-12 months duration, probably demanding 4-5 days per week. The successful candidate will be based in the European HQ in Greater London / Thames Valley, although it is likely that some work some work can be conducted from a home base. A modest amount of international travel will be required.
For the right candidate, the possibility exists for a subsequent transition into a permanent position of employment.
It is likely that the successful candidate will have…
- Advanced degree in Pharmacy/Medicine/Pharmacology/Chemistry/Biology or other science-related field.
- Master Degree in Regulatory Affairs a plus.
- Minimum of 15 years of experience in the pharmaceutical regulatory field
- Minimum of 4 years experience in a senior Regulatory position at European level
- Minimum of 4 years experience in Regulatory Affairs Director position within a EU5 country
- Previous people management experience across countries is required
- Working knowledge of Regulatory Affairs regulations and major European health authorities. Knowledge of Middle-East regulations is a plus.
- Experience of working in a specialty care category/disease space e.g.,psychiatry, mental health, stigmatizing diseases (HIV-HCV, alcohol addiction) is essential. Experience in controlled substance regulations is a plus.
This is an outstanding and exciting opportunity in an ambitious and fast-growing company. The contribution to be made will be highly visible and of critical importance.
If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@interea.co.uk
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