Sr Director, Regulatory Affairs

Reference: 629682Posted: 2026-08-06Location: New York, New YorkCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io call with HM scheduled for tomorrow at 1pm est. Location: REMOTE EST Salary: MarketJob Title / Position:Director/Senior Director Regulatory AffairsDepartment:Regulatory AffairsLine Manager / Supervisor Job Title / Position:Ellery MangasPurpose of JobThe Director/Senior Director of Regulatory Affairs will report to the Vice President of Regulatory Affairs and serve as a global liaison to regulatory authorities for gene therapy productsMajor Activities and ResponsibilitiesDevelop and implement global regulatory strategies that support efficient development and registration of gene therapy products.Work proactively in a cross-functional organization to help execute effective regulatory strategies in alignment with nonclinical, CMC and clinical development plans and portfolio strategy Lead the preparation, review, and submission of regulatory applications including: INDs/CTAs and amendments, BLAs/MAAs and supplements, Annual Reports, PIPs/PSPs and specialty designation applications (e.g., Fast Track, RMAT, PRIME, ILAP)Prepare for and lead negotiations with FDA, EMA, MHRA and other health agencies. This includes, preparing responses to questions and inquiries from health authorities, overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.Independently manage projects and execute as the RA lead, both in an operational and technical roleReview critical regulatory communications and evaluate conformance with regulatory requirements, clarity, and completenessIdentify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks Work with Regulatory CMC and Regulatory Operations to prepare, produce and submit health authority documents using internal and external resourcesManage contracted third party providers Key Performance IndicatorsAchievement of product development milestonesMaintenance of compliance with product reporting requirements Key Job CompetenciesExcellent organizational, communication and time management skills Thorough knowledge of the drug research, development, and commercialization processesCross-functional leadershipStrategic planning and ExecutionStakeholder communication and influencingExternal partner managementAbility to set and achieve challenging goals, demonstrate persistence and overcome obstacles and measure self against standard of excellenceSpeaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetingsWrites clearly and informatively; edits work for spelling, grammar and formatting; varies writing style to meet needs; able to read and interpret written informationSensitivity and experience with non-domestic organizations/cross-cultural environmentsQualificationsBachelor’s degree in scientific discipline with 10+ years of pharmaceutical industry experience, predominantly in Regulatory Affairs Master’s degree, PharmD, or PhD preferredRAPs certification preferred, but not required