Associate Vice President, Regulatory Science and Strategy, EU Liaison in Linton

Job Overview

Location
Linton, Scotland
Job Type
Full Time
Salary
TBC
Date Posted
6 days ago

Additional Details

Job ID
60074340
Job Views
1

Job Description

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 Vice President, Regulatory Science and Strategy, EU Liaison to support the success of our LVV gene therapy programs. They will provide strategic leadership to oversee and direct all EU regulatory activities, including developing and implementing strategies for investigational product development through post-approval activities to ensure achievement of business objectives. The AVP will serve a critical role in developing global strategy and will serve as the lead in EU regulatory activities.
Responsibilities:
Develop global regulatory strategies in collaboration with regulatory leadership aimed at gaining the earliest possible regulatory approvals internationally as well as for life cycle product management, with primary responsibility for EU activities.
Manage and provide leadership for all EU Regulatory activities including MAA and CTA activities.
Guide and/or lead regulatory agency interactions, including communications and meetings.
Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC) and labeling).
Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory-compliant submissions.
Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
Provides expertise in translating regulatory requirements into practical and workable plans.
Serves as a key member of the product team and leadership team and contributes to the development of product and business strategies to maximize the value of the company's portfolio.
Requirements:
Minimum BA/BS Degree with 15+ years pharmaceutical industry experience - prefer knowledge of biotechnology / gene therapy products, including multi-disciplinary experience, 10+ years regulatory strategy experience, or 8+ years of regulatory strategy experience and/or related experience (gene/cell therapy experience preferred).
Experience supporting both early and late phase development, including development and filing of associated regulatory submissions, with particular emphasis on MAA filing.
Strategic, dynamic, highly collaborative, and successful senior executive with significant experience and a successful track record with global regulatory leadership in both development-stage programs and marketed products.
Proven success in interfacing and responding to relevant global regulatory authorities, especially with respect to gene therapy products.
Ability to drive meetings with various stakeholders: (i) senior management, (ii) regulatory agencies, (iii) expert advisors (iv) collaborators and (v) project teams.
Stature, experience, technical credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders (CMC, preclinical, statistics, business development, legal, etc.) and externally among regulatory agencies.
Experience in rare disease and/or pediatrics and gene/cell therapy is preferred.
Thrive in a fast paced environment combining strategic and tactical capabilities.
Excellent written and verbal communication skills, analytic and problem-solving.
Travel Requirements ( 10%)

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.

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