Associate Director, Regulatory Affairs

The WEP Clinical Associate Director of Regulatory Affairs is responsible for understanding, developing, and leading the Regulatory Affairs strategy for Global Expanded Access Programs (EAP), Open Label Extension (OLE), and Post-Approval Named Patient Programs (PA-NPP).

Responsibilities

Provide Regulatory operational oversight and support to expedite the development and delivery of safe and effective healthcare products to individuals around the world; Provide guidance regarding current EAP, OLE and PA-NPP regulations and guidance (US, EU, UK and ROW); Provide guidance and support with regards to domestic licence regulations and requirements; Maintain domestically held licences from the competent authorities (US); Oversee the development of global, regional, and multi-country strategies and update based upon regulatory changes; Interact with regulatory authorities during the EAP, OLE and NPP review process to ensure approval; Responsible for the successful delivery of regulatory guidance for internal projects teams; Responsible for the line management of Regulatory Affairs staff including leadership, oversight, training, and development; Responsible for building and maintaining positive client relationships; Assist in the development and delivery of proposals in bid defences and capability presentations to perspective clients as the representative for WEP Clinical Regulatory Affairs

Requirements

Bachelor’s degree (legal, life sciences, or scientific equivalent preferred); 7+ years of broad regulatory experience; Effective verbal and written communication skills; Strong organizational skills and attention to detail; Computer literacy and proficient in Microsoft Office; Ability to handle extremely confidential information with complete discretion; Previous experience in developing regulatory strategy; Pro-active and solutions driven, with ability to meet multiple tasks and deadlines with a high level of accuracy

Nice to have

Exposure to Expanded access, Compassionate use, Open Label Extension, and Post Approval Named Patient programs preferred

Benefits

Group Private Medical Insurance; Group General Life Assurance; Group Critical Illness and Group Income Protection; Salary sacrifice pension scheme; Enhanced maternity & paternity pay; Educational Assistance allowance; Paid volunteering day