Associate Director, Regulatory Affairs

Who We Are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The Opportunity

You will be supporting global regulatory activities or leading all regulatory activities for a region or therapeutic area from early development through BLA. You will be an integral part of BLA filing activities currently underway. You will provide the organization with the leadership and strategic support to enable high quality and effective health authority and team communications to effectively drive the development process. You may also manage a regulatory staff for therapeutic areas, will recruit, assign workload, and perform performance appraisals.

What You'll Be Doing

• Responsible for supporting/leading multiple gene therapy development programs across therapeutic areas for a particular region
• Working closely with the Global Regulatory Leads, defines and implements the global strategy for early Health Authority interactions through BLA/MAA registration
• For assigned therapeutic areas, manages all submission activities and performs regulatory writing such as pre-IND, Orphan/breakthrough designations, Scientific Advice, End of Phase I/II and pre-BLA/MAA meetings
• Provides regulatory advice to cross-functional teams including requirements for product development and registrations
• Interacts with colleagues in other departments, other R&D functions and RA functions to deliver high quality dossiers, documents and materials in accordance with business priorities
• Responsible for providing regulatory research on potential new products and interacting cross-functionally to support development of innovative strategies on new products
• Support work with regional experts in EU, Japan and elsewhere to develop ex-US regulatory strategies. May lead interactions with local Regulatory Agencies via email, phone, or in-person meetings, depending on projects
• Travel up to 15% of the time may be required.
  
  
  
  
  

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• Minimum MS, preferred a PharmD or PhD in biological sciences
• 3-7 years in Regulatory Affairs experience, preferably in industry and including project management experience. Expert knowledge of regulatory affairs within one or more therapeutic areas
• Previous regulatory experience helping a team prepare for a Major Health Authority interactions (e.g. pre-IND meetings, End of Phase meetings, FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, etc.)
• RAC certification is a plus
• Highly resourceful team-player, with the ability to also be extremely effective and influential across functional areas.
• Proactive and creative approaches to problem-solving
• Strong written and oral communication skills; comfortable communicating with and building relationships with various internal stakeholders
• Experience with in resolving global regulatory issues in a collaborative fashion
• Experience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations
  
  
  
  
  

Why Should You Apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.