Job Description
Sr. Director, CMC Regulatory Affairs
Our team at The RFT Group enjoy a long track record of success recruiting the best available talent who are passionate about taking responsibility for building /establishing effective strategies for a range of truly exciting early innovation driven pharmaceutical companies. This role is hybrid, based in Ireland.
Sr. Director, Regulatory Affairs at this young exciting early start up will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product. In this hands-on role, s/he will provide dynamic leadership and direction to multi-disciplined project teams and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also support and provide key contributions to department and company initiatives related to regulatory affairs operations and strategy.
Job Spec
· Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals as assigned, including regulatory strategy development.
· Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks.
· Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape. Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
· Evaluate proposed CMC changes for global impact and provide sound regulatory strategies that support compliant change implementation.
· Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, NDA/MAA, pre-meeting briefing documents, etc.).
· Serve as the primary interface for FDA on assigned projects.
· Prepare and lead teams through successful regulatory meetings and interactions.
· Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice as it related to pharmaceutical development and quality.
· Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
· Participates in Business Development efforts, as assigned.
Person Spec
· Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 10 years pharmaceutical industry experience, including 5-7 years in CMC Regulatory Affairs. Global experience desired.
· Good understanding and knowledge of small molecule manufacturing and analytical methods is desired.
· Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
· Knowledge of global regulatory regulations and guidances as they relate to the overall global regulatory strategy.
· Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
· Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
· Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
· Domestic and occasional International travel may be necessary.
CV’s to gerry@rftgroup.ie / 00 353 1 2302400