DynPort Vaccine Co LLC, a GDIT company, is seeking a Regulatory Affairs Manager. This individual will provide support to a multi-disciplinary team through the preparation and management of CMC, nonclinical an clinical submissions, including INDs, Annual Reports, BLAs, NDAs and supplements/amendments and application of knowledge of regulatory requirements for human drugs and/or biologic products.
DVC was selected as the 2017 Best Place to Work among large employers in Frederick County, Maryland (See http://www.discoverfrederickmd.com/news/frederick-county-best-places-to-work-honored). In receiving the award, it was recognized that DVC treats our staff with fairness, maintains a great business culture, and finds special ways to enhance the overall work experience. At DVC, performance—with work/life balance—is the norm.
The successful candidate becomes an important champion for this extraordinary company culture and will have the opportunity to make substantial contributions toward the development of vaccines and therapeutics that will protect civilians and dedicated Armed Forces men and women.
**This position is currently 100% remote due to COVID-19, but will be based in Frederick, MD once restrictions are lifted.
Typical Duties and Responsibilities:
Implement regulatory filing strategies in support of Domestic and International filing initiatives.
Serve as the DVC RA Representative on product teams and committees.
Interface with appropriate internal departments such as Product Technical Services, Clinical Research, Nonclinical and Quality Assurance to ensure timely submissions, including tracking of communication to and from the FDA, Europe, Canada and international regulatory authorities.
Secondary point of contact with FDA, Europe, Canada and international regulatory authorities.
Assist the Associate Director/Director of Regulatory Operations in the preparation and assembly of submissions to regulatory agencies.
Interface with internal departments to oversee the support and ensure timely submissions to regulatory agencies.
Ensure that all CMC/nonclinical/clinical documentation, which directly or indirectly supports the preparation of regulatory submissions, are prepared to meet domestic and international requirements.
Proactively identify potential product development problems/issues and support corrective action plans for resolution.
Maintain proficiency in current applicable FDA guidelines and regulations.
Bachelors degree in biological sciences. Masters degree preferred.
5+ years of experience in the biopharmaceutical industry with writing/review of regulatory documentation (INDs, batch production records, amendments, BLAs, NDAs, safety reports and/or supplements).
5+ years of cGMP and/or clinical experience in the biopharmaceutical industry.
Thorough knowledge of regulatory requirements for human drugs and/or biologics, including pre-clinical, clinical, chemistry and manufacturing activities associated with IND and license applications.
Direct experience preparing and managing CMC, nonclinical, clinical submissions including IND, Annual Reports, BLAs, NDAs and supplements.
Ability to think both strategically and tactically is essential.
Strong leadership, communication (verbal and written), project management and presentation skills.
Excellent time management and organizational skills to meet project deadlines.
Ability to interact with multiple levels of DVC management and subcontractors.
Proven ability to manage and prioritize multiple tasks.
Ability to provide support to a multi-disciplinary team.
WHAT GDIT CAN OFFER YOU
Autonomy, career mobility, challenging work, and team environment
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.