We're looking for a candidate to this position in an exciting company.
Provides guidance and leadership to the members of the regulatory affairs teams.
Directing all regulatory activities as well as developing necessary SOPs
Develops global regulatory plans and strategies that support client's investigational and to-be marketed products
Develop and implement strategies for the timely preparation and execution of submissions to regulatory authorities for all phases of the product life cycle.
Provide expert analysis of regulatory information and is able to properly communicate with C-Suite and other stakeholders
Analyze and make recommendations for improving internal and vendor compliance with the FDA and international regulatory authorities as well as ICH quality regulations and guidelines.
Communicate with US and other international regulatory agencies; ensures the company is compliant with US and international regulatory requirements
Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures
Prepare/oversee the preparation of meeting requests, briefing documents, coordinate and prepare team for meetings, and interface with regulatory authorities, be primary liaison with regulatory authorities for day-to-day interactions.
Coordinate and prepare responses to requests for information from regulatory authorities
Develop and manage a global budget supporting regulatory department
Hire, mentor, and support the personal and professional development of regulatory staff
Minimum of 10 years of drug development regulatory experience
PhD preferred; or science based degrees
History of successful interactions with regulatory HAs (FDA/EMA),
NDA and MAA experience, IND and CTA experience with small molecules.
Experience developing early and late-phase oncology products
Knowledgeable of US, EU and international regulatory affairs, GXP compliance and associated regulations.
Must have experience in the preparation and submission of regulatory documents (IND/CTA/NDA/MAA)
Knowledge and understanding of global regulations and guidelines
Proven management and leadership experience, including identification and development of talent.
Boston, Boston, England, Lincolnshire, PE21, United Kingdom