Regulatory Operations Manager

POSITION SUMMARY

This position of Regulatory Operations Manager will provide day-to-day support to the Regulatory Affairs group in the area of regulatory operations to ensure compliance with Food and Drug Administration (FDA) regulations for pharmaceuticals. 



DUTIES & RESPONSIBILITIES

1. Serve as the primary regulatory contact for project-specific regulatory submissions.
2. Prepare, write, and submit hard-copy and electronic communications to the FDA necessary to maintain a coherent, complete, and articulate dialog with regards to specific to intra- and inter-disciplinary projects.
3. Assume regulatory lead for IND and NDA maintenance by coordinating regulatory workflow, providing regulatory support to the team. and tracking regulatory project timelines.
4. Manage comprehensive regulatory submission processes and flows to enable quality regulatory submissions (INDs, NDAs, CTDs/e-CTDs, PSURs).
5. Oversee initiatives aimed at improving internal regulatory standards and systems, including, for example, document control and security
6. Ensure that assigned regulatory timelines are properly established, maintained and on-target.
7. Design and complete/compile regulatory plans and regulatory submissions.
8. Review and format key technical documents.
9. Interface with manufacturing, pharmaceutical development, clinical research, pre-clinical and other functional group personnel as needed.
10. Review and analyze proposed modifications to marketed products for regulatory impact.
11. Read, review, interpret, and keep current with regulations and publications regarding drug and device products to provide technical assistance and direction to various functional group teams.

The successful candidate should possess:

+Minimum of 5 years direct experience in regulatory affairs in a comparable role.
+Bachelors Degree in a scientific or related discipline required.  An advanced degree is desirable.
+Previous practical experience preparing, filing and maintaining medical product regulatory submissions, with demonstrated knowledge of FDA regulations in the post approval drug area.
+Full understanding and working knowledge of all .phases of the drug approval processes, specifically the Phases III, IIIb and IV.
+Outstanding verbal and written communication skills
+Excellent organizational and planning skills, with the ability to handle multiple projects and possess ability to prioritize
+Strong proficiency in MS Office applications, with an in-depth knowledge of Word, familiarity with Project and Excel.
+A very high attention to detail.
+Must be team player yet has ability to work independently within project teams

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Richmond, VA
County:	Richmond City County
ZIP Code:	23218
Pay Rate:	Competitive
Job Terms:	full time
Company:	Discovery Solutions, Inc.
Phone:	(443)402-1582
Fax:	410-510-1240