Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health bene fits.
Rocket is seeking an Associate Director, Regulatory Operations to support the development and implementation of the global regulatory strategy of Rocket's gene therapy programs in accordance with regulations and through collaboration with external partners, internal cross-functional teams, and global health authorities.
Work closely with regulatory affairs to provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans to support efficient development and pathway to global registration. Manage all aspects of submission planning (creation and maintenance) and publishing and/or submission components including all operational tasks associated with or in support of authoring (formatting, editing, reviewing) Interface with other departments and outside consultants to establish submission timelines, obtain on-time deliverables and ensure regulatory compliance for planned submissions in a Regulatory Operations project management role Responsible for the preparation (eCTD documentation readiness), dispatch, tracking and archiving of electronic submissions for developing and marketing applications Assist with development and submission of high-quality regulatory documents (e.g., INDs, CTAs, Amendments, Orphan Drug Applications, Pediatric Study Plans, Regulatory Designation Requests, Special Protocol Assessment requests, Marketing Applications, and Responses to Health Authority questions) Responsible to perform final document review (QC) prior to finalization and conversion to a submission ready PDF format Maintain regulatory submissions filing and Health Authority correspondence logs with tracking system Lead development and implementation of process documentation including, SOPs, Work Instructions, and Best Practices related to Regulatory Operations BS Degree with 12 years pharmaceutical industry experience – prefer knowledge of biotechnology / gene therapy products, including multi-disciplinary experience. Proven strong expertise in the eCTD process, document management environments/systems, publishing tools and submission software At least 8 years of Regulatory Operations experience required; with IND/BLA/NDA/CTA/MAA filing experience. Experience in working with 3rd party vendors in support of IND/IMPD, BLA/MAA application submission. Technical expertise in handling electronic document management system (EDMS). Thorough knowledge of electronic Common Technical Document submission requirements. Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills. Thrive in a fast - paced environment combining strategic and tactical capabilities A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
