Associate Director, Regulatory Science and Strategy - EU Liaison

Cambridge /
Regulatory – Regulatory Affairs /
Full Time
/ Remote
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.

Rocket is seeking an Associate Director, Regulatory Science and Strategy - EU Liaison Liaison  to support the success of our gene therapy programs in the EU. They 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 and in collaboration with the RA team.
    • Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals (with support from leadership).
    • Leads preparation of key regulatory documents (e.g., MAAs, CHMP Scientific Advice, PIPs), working closely with cross functional colleagues and external consultants as required.
    • Leads question/response and interactions with European regulatory agencies (e.g., EMA, MHRA).
    • 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).
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.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.