Senior Manager, Regulatory Affairs (EU)

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.

Position Summary

Rocket is seeking a Senior Manager, Regulatory Affairs to support the success of our gene therapy programs across LV and AAV platforms in the EU. S/he will manage regulatory activities related to CTA and MAA submissions, health authority interactions, and implementation of global regulatory strategies .

Responsibilities

• Ensures alignment of EU activities with the overarching global regulatory strategy in support of the development, registration, and life-cycle management of Rocket’s products.
• Responsible for leading high-quality CTA submissions and CT life-cycle management in coordination with a cross-functional team (CTIS/MHRA).
• Assists with development and submission of key regulatory documents/briefing documents (e.g., CHMP Scientific Advice, PIPs, ODD, PRIME), working closely with cross functional colleagues and external consultants as required and life-cycle management activities (OD annual report, DSUR submissions, etc).
• Supports preparation of MAA regulatory documents and supports related processes and strategy to ensure timely product approvals.
• Leads question/response and interactions with European regulatory agencies (e.g., EMA, MHRA). Ensures regulatory compliance and timely implementation of health authority advice/commitment based on maintenance of all Health Authorities interactions/ feedback.
• Takes ownership and responsibility for regulatory projects, working collaboratively with stakeholders internally and externally.
• Monitors emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
  
  

Qualifications

• Minimum BS Degree with 6+ years pharmaceutical industry experience with 3+ years in regulatory – prefer knowledge of biotechnology / gene therapy products.
• Experience in European Regulatory procedures and agency interactions.
• Proficient in the use of submission and health authority interaction tools (CTIS, IRIS, eGateway, Eudralink…).
• Experience in interfacing and responding to relevant global regulatory authorities.
• In-depth knowledge of European guidelines including the CTR and EU Centralized Procedure; Practical understanding, interpretation, and application of relevant ICH and EMA guidelines
• Thrive in a fast‐paced environment combining strategic and tactical capabilities.
• Excellent written and verbal communication skills, analytic and problem-solving skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders.
• Ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Sense of urgency and perseverance to achieve bringing curative therapies to patients.
  
  

EEO Statement

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.