Manager, Regulatory Affairs
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 benefits.
Make a difference in patients’ lives one submission at a time!
Rocket’s Regulatory organization provides unmatched expertise related to global regulatory activities through all stages of product lifecycle and is at the forefront of shaping a dynamic regulatory landscape in gene therapy. Today’s work at Rocket will create a roadmap for many years of future gene therapy approvals. Rocket’s pipeline of first-in-class therapies and numerous expedited review designations yields unprecedented opportunities to interact with health authorities and build collaborative relationships. This dedicated organization features some of the best talent in the world with a shared mission to deliver curative gene and cell therapies for rare and devastating diseases.
Rocket is seeking a Manager, Regulatory to support the success 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 cross functional 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 guidance/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 Sciencesrequired; 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 ICHguidelines
- 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
Location: Cranbury, NJ
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.
Learn more here
Job posted: 2021-04-18