Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs Apply Location Cambridge, MA No Remote Type Direct Hire ID FL181-2723312 Posted Apr 13, 2023 We are seeking an experienced Associate Director for our Global Regulatory Affairs team within our Life Sciences Division. The successful candidate will have a proven track record on filing and liaising with regulatory authorities, specifically the US Food and Drug Administration and European Medicines Agency including Medicines & Healthcare Products Regulatory Agency of the United Kingdom. Experience in Oncology or new therapeutic modalities is preferred.As the Associate Director, you will provide expert guidance in the following key areas:· Submissions for regulatory applications, including Investigation New Drug, New Drug Application or Biological License Application· Reviewing archived regulatory applications and assessing any clinical hold issues· Coordinating and submitting requests for regulatory meetings and interacting with regulatory authorities· Leading the development and submission of regulatory expedited programsThe ideal candidate will have:· Advanced degree in life sciences from an accredited institution· Minimum 3-5 years of pharmaceutical industry experience· Hands-on experience in regulatory submissions and interactions with regulatory authorities· Experience in regulatory expedited programs for new therapeutic modalities is a plus· Strong communication skills and a scientifically driven mindset· Entrepreneurial mindset and passion for building successful assets· Excellent analytical and problem-solving skills, with the ability to work well under pressure· Strong leadership ability, including flexibility and innovation· Ability to represent the organization as a regulatory affairs expert and to influence in a matrix environment· Proficiency in solving problems with superior judgment, and the ability to act with grace and resilience under pressureThe position requires flexible working hours, with the ability to travel (international or domestic), and the expectation to be office-based when not travelling.