|
Regulatory Affairs Manager, Generics, Greensboro, North Carolina
| $90,000 - $95,000 + Bonus
We are seeking a Regulatory Affairs Manager
for our pharmaceutical company client.
You will manage regulatory activities to achieve registration goals
of generic drugs through interactions with Federal agencies to ensure generic products receive regulatory approval.
1- Responsible for Regulatory strategy to register all generic products in the US. Negotiates generic drug development
plans with FDA/CVM.
2- Maintains communication with US Regulatory Affairs, Global Regulatory Affairs, US
Regulatory Affairs and the FDA/CVM Generics Drugs team relating to obtaining generic drug approvals and maintaining approval
status.
3- Responsible for importation of documentation into internal database and assuring imported
documentation is accurate, legible and complete.
4- Authors company or departmental standard operating procedures
addressing regulated processes as appropriate.
5- Provides input into strategic planning to achieve global,
regional and departmental goals for generic project approvals and life-cycle management. Coordinates with Technical Ops, Quality,
Regulatory Affairs and Regulatory Affairs to meet pre and post approval regulatory reqs.
Experience
required: - MS, PhD, PharmD- or other advanced scientific degree req
- Several years of work exp- w/ proven track record of registering generic drugs (veterinary
or human)
- Detailed knowledge and understanding of required manufacturing
documentation necessary for registration of generics
- Proven experience
maintaining positive working relationship w/ regulatory agencies
- Proven
experience working w/ cross functional teams strategically across projects
- Global
experience required
Please email your cover letter and resume to
ruth@pharmacruiting.com |
|
