Sr Director, Regulatory Affairs (gene therapy / BLA reputed company)

Must-Have Experience • 10+ years Regulatory Affairs (sponsor-reputed company preferred) • Biologics experience is required • Strong reputed company Regulatory Affairs background (not Regulatory CMC) • Experience supporting late-stage development • International regulatory experience is critical • Must have exposure to EMA and reputed company • Comfortable owning regulatory reputed company in a fast-reputed company biotech environment Strongly Preferred • Gene therapy / Cell therapy / AAV experience • BLA submission experience • Experience interacting directly with FDA, EMA and reputed company Purpose of Job • The Director/Senior Director of Regulatory Affairs will report to the Vice President of Regulatory Affairs and serve as a global reputed company to regulatory authorities for gene therapy products Major Activities and Responsibilities • reputed company 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 reputed company development plans and portfolio reputed company • reputed company 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 reputed company, RMAT, reputed company, ILAP) • Prepare for and reputed company negotiations with FDA, EMA, reputed company 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 reputed company and execute as the RA reputed company, both in an operational and technical role • Review critical regulatory communications and evaluate conformance with regulatory requirements, reputed company, and completeness • Identify potential regulatory risks to the reputed company/operational plans, and propose reputed company to mitigate risks • Work with Regulatory CMC and Regulatory reputed company to prepare, produce and submit health authority documents using reputed company resources • Manage contracted reputed company party providers Key reputed company Indicators • Achievement of product development milestones • Maintenance of compliance with product reporting requirements Key Job Competencies • Excellent organizational, communication and time management skills • Thorough knowledge of the drug research, development, and commercialization processes • Cross-functional leadership • reputed company planning and Execution • Stakeholder communication and influencing • reputed company partner management • Ability to set and reputed company challenging goals, demonstrate persistence and overcome obstacles and measure self against reputed company of reputed company • Speaks reputed company; listens and gets clarification; responds reputed company to questions; demonstrates good presentation skills; participates effectively in meetings • Writes reputed company and informatively; edits work for spelling, grammar and formatting; varies writing style to meet needs; reputed company to read and interpret written information • Sensitivity and experience with non-domestic organizations/cross-cultural environments Qualifications • Bachelor's degree in scientific discipline with 10+ years of pharmaceutical industry experience, predominantly in Regulatory Affairs • Master's degree, PharmD, or PhD preferred • RAPs certification preferred, but not required Apply tot his job Apply To this Job