What are the responsibilities and job description for the Regulatory Affairs Specialist III position at AGTC?
Mission
The Regulatory Affairs Specialist III is responsible for coordinating the preparation and submission of documents to regulatory agencies and organizing and maintaining related records.
Reporting Relationship
- The Regulatory Affairs Specialist III will report to the Associate 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
Educational Qualifications
- B.S. degree in a scientific discipline
- A minimum of five (5) years’ experience working in a biomedical research field
- Regulatory Affairs experience with eCTD format preferred
- Experience working with biotechnology products preferred
Additional Qualifications
- Knowledge of GLP, GMP, GCP and FDA regulations
- Understanding/working knowledge of Microsoft Word, Excel and Adobe Acrobat
- Strong interpersonal, negotiating and problem -solving skills
- Excellent communication skills, both written and verbal
Physical Requirements
- Physical demands:
|
☒ sedentary (< 10 lbs.) |
☐ light work (< 20 lbs.) |
☐ medium work (< 50 lbs.) |
|
☐ heavy work (< 100 lbs.) |
☐ very heavy work (> 100 lbs.) |
|
- Physical activity:
|
☒ repetitive motion |
☒balancing |
☐stooping |
☐lifting |
☐climbing |
|
☐kneeling/crouching |
☐crawling |
☒reaching |
☒standing |
|
|
☒ typing/grasping |
☐ walking |
☐pushing/pulling |
☒ hearing |
|
- Visual acuity: reading, writing
- Working conditions: indoor
Supervisory Responsibilities
- Previous management or supervisory experience not required