Rocket offers the unique opportunity to be at the forefront of innovation while working alongside motivated team members to bring best-in-class curative gene therapies for patients with devastating diseases. The ideal candidate is action oriented, life-long learner who are inspired to make an impact for patients. The Regulatory Affairs Manager will support the development and implementation of global regulatory strategy of Rocket’s gene therapy programs in accordance with regulations and through collaboration with external partners, internal crossfunctional teams, and global health authorities.
- Support the preparation and implementation of the regulatory strategic and operational plans to support efficient development and pathway to global registration
- Assist with development and submission of high quality regulatory documents (eg INDs, CTAs, Amendments, Orphan Drug Applications, Pediatric Study Plans, Regulatory Designation Requests, Special Protocol Assessment requests, Marketing Applications, and Responses to Health Authority questions)
- Routinely performs regulatory precedence and competitive intelligence research
- Routinely tracks and communicates implications of changing global regulatory requirements eg health authority guidances/guidelines, regulatory policies, overall environment relevant for gene therapies
- Supports the planning and execution of global health authority interactions including support in generation and submission of briefing books; meeting preparations
- Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submission and approval
- Responsible for development and on time submission of annual reports
- Ensures regulatory compliance and timely implementation of health authority advice/commitment based on maintenance of all HA interactions/ feedback
- Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines
- Collaborates with and manages regulatory consultants and other vendors as required
- Strong scientific background. BA/BS/University degree in Life/Health Sciences required; advanced degree preferred (PharmD, MD, PhD)
- 2-4 years of regulatory development experience in the biotechnology/ biopharma/ pharma industry
- Knowledge and understanding of US and international regulations including ICH guidelines
- Experience and knowledge in the preparation of global regulatory submissions including maintenance activities
- Strong team player who demonstrates ownership and looks for opportunities for continuous improvement
- Thrive in a fast-paced environment combining strategic and tactical capabilities
- Excellent written and verbal communication skills, analytic and problem-solving
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org