Director Global Regulatory Affairs

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.