POSITION SUMMARY The Manager/Senior Manager, Regulatory Affairs is responsible for supporting all Regulatory activities for retinal and metabolic therapeutic areas from early development through BLA. The incumbent will support the organization with high quality submissions and effective health authority and team communications to effectively drive development process. The core duties and responsibilities of the Manager/Senior Manager, Regulatory Affairs are detailed below.
Responsible for contributing to and implementation of regulatory strategies for multiple development programs in the therapeutic area, under the direction of the Senior Director.
Working closely with the Senior Director, Regulatory Affairs, implements and supports the global strategy for Health Authority interactions through BLA/MAA registration
Conducts and analyzes regulatory research, understanding regulatory environment and guidelines pertaining to program area
For the assigned program areas, leads or supports all submission activities and responsible for regulatory writing such as pre-IND, IND amendments, annual reports, orphan designations, Scientific Advice, health authority meeting briefing packages.
Represents regulatory on cross functional sub teams such as clinical trial teams; provides regulatory advice including submission requirements for product development and registrations.
Interacts and communicates 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
Work with local agents and experts in countries outside of the US to implement regional regulatory strategies as applicable.
Leads regulatory sub teams
Contribute to department initiatives to develop procedures and working practices
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
Bachelor’s degree in a scientific discipline
Minimum of 4–6 years in Regulatory Affairs or equivalent related experience in developing regulatory documentation for Health Authorities
Some experience in biologics development preferred
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
TECHNICAL SKILLS Experience with preparation of high quality FDA/EMA submission documentation
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
Normal working conditions
Internal Number: REG-18-00002
About Regenxbio Inc.
REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. Our NAV Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. Our mission is to transform the lives of patients suffering from severe diseases with significant unmet medical needs by developing and commercializing in vivo gene therapy products based on our NAV Technology Platform. We seek to accomplish this mission through a combination of our internal development efforts and the efforts of our third-party licensees (NAV Technology Licensees).
Our most advanced internally developed candidates include programs for the treatment of two severe and rare genetic diseases, homozygous familial hypercholesterolemia (HoFH) and Mucopolysaccharidosis Type I (MPS I). In addition, we have a preclinical program for wet age-related macular degeneration (wet AMD) as well as two additional research programs. REGENXBIO plans to build internal gene therapy franchises in the metabolic, neurodegenerative and retinal therapeutic areas, and develop multiple product candidates in these and other areas.