Key Responsibilities:To have an in-depth scientific and regulatory knowledge of the therapeutic area and regulatory landscape in Europe, Turkey, Israel and Switzerland providing comprehensive regulatory...
My Client a Biotech Company, listed on the Nasdaq Stock Market and with offices and laboratories in both Salisbury, UK and Cambridge MA, USA is focussed on the discovery, development and commercialisation of products for treatment of diseases with unmet needs. A new opportunity has arisen within their Regulatory team for a Director of Regulatory Affairs to join their small team in this fast-paced working environment. This is a permanent role based in the UK office.
The Director, Regulatory Affairs will provide strategic direction for regulatory activities on all development programmes, ensuring they are in line with Company objectives.
Set the regulatory strategy for each development project in accordance with Company objectives and provide regulatory expertise.
Prepare, manage and submit IND/CTA applications in accordance with project goals and ensure development programmes will meet the regulatory needs for NDA/MAA.
Prepare and manage the submission of Orphan Drug Designations, Breakthrough Designations and other applications as required.
Manage meetings with Regulatory Agencies (e.g. Scientific Advice, Pre-IND and EOP2 meetings) including preparation and submission of Briefing Documents, briefing of the team and follow-up.
Direct and manage the Regulatory team to ensure continued professional development and motivation and manage the annual regulatory budget.
Maintain an up to date knowledge of all applicable FDA/EU/other international regulations and laws and undertake training and/or information sharing with colleagues to ensure all changes are implemented within appropriate processes to maintain compliance.
Provide regulatory expertise for the product development teams and maintain SOPs for regulatory activities and ensure compliance.
Minimum BSc or equivalent within Life Sciences.
Extensive direct experience in regulatory affairs with recent hands on experience of preparing, submitting and gaining successful approval of CTA/INDs and MAA/NDAs.
Direct experience of providing regulatory support for clinical development from First in Human to NDA/MAA for a range of indications and pharmaceutical forms.
Proven ability to manage a team.
Ability to write and maintain regulatory SOPs.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.