REGENXBIO INC. Rockville MD United States
1 week ago
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.
In this role, you will be responsible for supporting Regulatory activities from early development through BLA. You will have the opportunity to support REGENXBIO in providing high quality submissions and effective health authority and team communications to effectively drive the development process.
What you’ll be doing
• Contribute and implement regulatory strategies for multiple development programs
• Implement and support the global strategy for Health Authority interactions through BLA/MAA registration
• Conduct and analyze regulatory research, understanding regulatory environment and guidelines pertaining to program area
• Lead and/or support all submission activities and regulatory writing such as pre-IND, IND amendments, annual reports, orphan designations, Scientific Advice and other health authority meeting briefing packages
• Represent regulatory on cross functional sub teams such as clinical trial teams; provide regulatory advice including submission requirements for product development and registrations.
• Interact and communicate cross-functionally in order to deliver high quality dossiers, documents, and materials in accordance with business priorities
• Work with local agents and experts in countries outside of the US to implement regional regulatory strategies as applicable
• Lead regulatory sub teamsas needed
• Contribute to department initiatives to develop procedures and working practices
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:
• Bachelor’s degree in a scientific discipline
• Minimum of 4 years in Regulatory Affairs or equivalent related experience in developing regulatory documentation for Health Authorities
• Highly resourceful team-player, with the ability to also be extremely effective independently
• Proactive and creative approaches to problem-solving with strong decision-making capability
• Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners
• Experience with preparation of high-quality FDA/EMA submission documentation
• Some experience in biologics development preferred
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 bring 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.
Please be aware that REGENXBIO currently maintains a policy requiring all employees to be fully vaccinated against COVID-19. New employees must be vaccinated prior to their employment start date.
At REGENXBIO, we have a strong commitment to protecting our people. From the beginning of the COVID-19 pandemic, REGENXBIO has prioritized the health and safety of our people and is incredibly proud of our team as well as the perseverance exhibited over the last year. We believe that vaccinations are key to keeping our patients, team, and community safe and healthy. REGENXBIO, an Equal Opportunity Employer, will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law
Rockville MD USA
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Senior Manager, Regulatory Affairs Rockville jobs
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