Senior Associate, Regulatory Affairs
Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. The Senior Associate, Regulatory Affairs is responsible for coordinating the preparation and submission of documents to regulatory agencies and organizing and maintaining related records.
- The Senior Associate, Regulatory Affairs will report to the Sr. Director, Regulatory Affairs
Essential Duties and Responsibilities
- Plan and coordinate the drafting, editing, preparation and submission of regulatory filings (including routine correspondence, INDs, CTAs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.).
- Ensure proper filing and organization of all documents and correspondence in support of and concerning all regulatory submissions.
- Organize regulatory information and track and control submissions
- Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products
- Participate in research of regulatory issues and dissemination regulatory information to internal groups and senior management as required
- Other duties as assigned
- B.S. degree in a scientific discipline
- At least 5 years’ experience working in a biomedical research field, including at least 3 years in Regulatory Affairs
- Experience working with biotechnology products preferred
- Knowledge of GLP, GMP, GCP and FDA regulations
- Understanding/working knowledge of the eCTD format, Microsoft Word, Excel and Adobe Acrobat
- Strong interpersonal, negotiating and problem -solving skills
- Excellent communication skills, both written and verbal
AGTC offers a competitive compensation commensurate with education and experience. AGTC is an EOE and maintains a drug free workplace. Please send CV or resume.