Company : Compass Life Sciences Location : Essex England
CompassLifeSciences have partnered with a Large International Pharmaceutical Company, ranked within the Worldwide top 20, in their search to appoint a RegulatoryAffairsAssociate – EU – Neuroscience.
You will be working within the Global RegulatoryAffairs – Innovative Medicine Europe Team with a primary focus on the Neuroscience therapeutic area and utilising your experience of European regulatoryaffairs .
This is a hybrid role with 2 days on-site in their North London/East Essex site.
Key Responsibilities:
You will work within the Global RegulatoryAffairs team, obtaining registrations for innovative products in Europe and ensuring that the registrations for existing marketed products are maintained.
You will be responsible for supporting key pre - and post-approval Regulatory activities performed by the TA Neuroscience team.
The position focuses primarily on innovative Neuroscience products, though there could be opportunities to also support activities for the Immunology TA in the future.
You will support and manage the preparation and submission of both centralised and/or decentralised Regulatory pre - and post-approval filings for innovative Neuroscience products in Europe You will coordinate regulatory aspects in connection with clinical Trial Applications (CTAs) in Europe You will co-ordinate Scientific advice, Paediatric Investigation Plan (PIP) procedures and other pre-approval regulatory activities with the EMA and/or national competent authorities as applicable You will participate in the development of RA strategies for assigned products You will support the development and/or subsequent maintenance of product labelling You will ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for the EMA or national competent authorities You will collaborate with internal and external teams, provide European regulatory advice to General Management and other departments (e.g.
Commercial, Medical, Clinical etc.) and project teams You will understand, and accurately follow guidance on all EMA/EC regulations, guidelines, procedures and policies and provide feedback to cross-functional teams as needed Knowledge & Experience:
Experience working in European RegulatoryAffairs (Essential) Experience in clinical development and pre-approval Regulatory activities (Desirable) A BSc degree in lifesciences, ideally with an MSc or PhD Good understanding of European regulatory requirements and guidelines Experience and knowledge of the eCTD Excellent written and verbal communicator Able to work under pressure to meet tight deadlines Offering a competitive base salary and benefits package including:
25 days of annual leave + Public Holidays, Flexible home working, Pension scheme, Life & Critical Illness Insurance, Private health insurance, Sports and Health Programme – including health days and nutritional counselling, On-site Canteen, Company bonus scheme, Virtual Learning Centre access.
If this sounds like the right role for you, then click apply or get in touch with Cameron Scott for more details at +44 (0)239 4211142 or cscott@compassltd.co.uk for a confidential chat.
Not right for you but know someone interested? Why not refer a friend or colleague for this exciting opportunity? CompassAssociates Ltd.
trading as CompassLifeSciences is acting as a Recruitment Consultancy for this permanent vacancy; we offer up to £1,000 worth of Amazon vouchers, for a successful recommendation, alternatively, a donation can be made to a charity of your choice. CompassLifeSciences EssexEngland
