Director/Senior Director, Regulatory Affairs, CMC

1 week ago

Rockville, United States CareerBuilder Full time

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 responsible for for leading all regulatory activities related to chemistry, manufacturing, and controls for each product development area from early development through BLA. The incumbent will provide the organization with the leadership and strategy to enable high quality and effective health authority and team communications to effectively drive development process. You will also supervise CMC regulatory staff for multiple product development programs, will assign workload, and oversee CMC staff development and perform management.
What youll be doing

Lead CMC quality execution of all CMC regulatory activities for biologics/gene therapy product development according to business priorities
In coordination with CMC leadership team, define and implement the global CMC strategy for early health authority interactions through BLA/MAA registration
Manage all CMC-related submission activities and oversees regulatory writing and timely delivery of high-quality technical documents including, briefing books, quality modules for clinical trial and marketing applications, drug master files, and responses to regulatory authority inquiries, while assuring all documents meet regulatory requirements and quality compliance
Interact 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
Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives
Work with local agents and experts in Brazil, European Union, Japan and other rest-of-world countries to develop regional CMC regulatory strategies
Provide leadership in the support of the regulatory documentation system(s) to reach excellence to ensure efficiency, traceability and compliance of regulatory CMC documents
Provide Represents CMC RA at health authority meetings and/or CMC-related conferences
Work with VP of Regulatory Affairs to identify resource needs, including consultants and new associates, advising on skills sets to meet needs
Develop regulatory manager and/or associate to lead CMC submission writing activities and provide high quality documentation for regulatory submissions
Coach regulatory manager and/or associate to provide regulatory advice to their cross-functional teams including requirements for product development and registrations
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
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:

Bachelors degree required, Advanced degree in biological sciences preferred.
A minimum of 10 years of experience in Regulatory Affairs, CMC Biologics (Bachelors degree requires at least 12 years)
Preference for experience in CMC gene therapy development
Experience with global regulatory quality requirements
Demonstrated ability to manage competing priorities to deliver on-time and high quality regulatory documents
Skills to build technical excellence and process efficiency in CMC across functional teams
Proactive 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 and health authorities
Highly resourceful team-player, with the ability to also be extremely effective independently
Experience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations 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, youll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

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