Are you looking to lead a European regulatory team for a pioneering Bio-pharmaceutical company? My client is a pioneering immunology company leading the market in allergy vaccines, they have developed an innovative approach to medical treatments over a number of decades and are in an exciting phase of expansion across Europe and the USA. The company has an excellent reputation for its welcoming atmosphere, staff morale and ongoing career development. They have a range of ongoing clinical trials in different countries and have created this new position in order maximise their new product pipelines.
Your role will be to lead the Regulatory CMC and Operations teams across the UK, Italy and Spain to deliver core CMC activities, all aspects of regulatory operations and local market objectives and will include:
- Managing and leading an expert team of Regulatory affairs professionals
- Creating and executing strategies to the meet the overall company R&D plan for reg CMC, labelling and operations aspects of the development approval of new products, alongside life cycle management activities for commercial products.
- Act as the primary point of contact in these areas for internal stakeholders including Commercial team, Quality Assurance team and Manufacturing.
- Managing the production of clinical trial IMPDs/INDs, MAA, PSURs, post-approval variations and renewals.
- Managing regulatory change control
- Update and improve regulatory systems to closely align with other internal groups
- Extensive Regulatory affairs CMC and operations experience
- Excellent knowledge of reviewing and preparing submissions
- Demonstrated line management experience
- Extensive knowledge of CMC for development and market products
- Experience with the management of change control processes
Benefits: In addition to a competitive salary (negotiable depending on experience), the company offers a very good benefits package including:
- Full flexibility to work from home 1-2 days per week
- Annual bonus
- Expenses for international travel
- Stakeholder pension plan
- Life insurance scheme
- 25 days’ holiday
- Long term disability scheme
- Private medical plan