Blackfield Associates are proudly partnered with an international pharmaceutical client on an exclusive basis, who are looking to establish a new team for their emerging markets division. To lead this team, we’re looking to hire a Regulatory Director to ensure successful registration, lifecycle management and global expansion of the portfolio, while providing leadership to a small team and working closely with affiliates and international stakeholders.
As Regulatory Affairs Director, you will:
* Lead and oversee a new, small RA international teams, providing leadership and regulatory strategic guidance ensuring successful and timely regulatory submissions
* Lead the preparation, submission, and approval of regulatory filings (new product registrations, existing product global expansion registrations, variations and other lifecycle regulatory activities) for the companies identified international markets with a portfolio of assets.
* Manage existing product dossier updating and remediation activities supporting global expansion of existing products into new markets- emerging markets/ LATAM and JPAC
* Liaise with country affiliate and distributor RA teams providing support for regulatory submissions, labelling and post approval submissions, and ensuring regulatory compliance
* Provide updates to senior leadership on regulatory submission activities as needed
* Analyse evolving global regulations, trends, and competitive landscapes within the EMEA international region
* Manage the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.
To be considered for the role of Regulatory Affairs Director, you will:
* Educated to degree or advanced degree in related life science field
* Significant Regulatory experience – 10 years plus – including strategic leadership and global experience in international markets
* Regulatory experience of Latin America and Asia countries is essential
* Experience managing regulatory registrations for existing products for global expansion
* Proven success in the effective management of timely approval of regulatory procedures in emerging markets
* Broad understanding of the requirements to place products on the market within EU
* The successful candidate will be an agile, autonomous and a leader, who wishes to be hands on and grow a new department
This is a permeant, full time role. Based from the companies affiliate office, you will need to be able to attend the Slough office on a hybrid basis.
Unable to sponsor, candidate must have full right to work in the UK and flexibility around working hours due to territories.