Senior Manager, Regulatory Affairs, Labeling Sagent Pharmaceuticals

Department:
Regulatory Affairs

Reports To:
Regulatory Affairs Associate Director

Classification:
Exempt

Basic Function:
Responsible for coordinating labeling activities with our partners and supervising labeling personnel

Education/Work Experience:
- Candidate must have expertise in pharmaceutical labeling regulations and cGMP manufacturing (pharma or diagnostics).
- Must have demonstrated project management experience
- Supervisory experience
- Regulatory submission experience is preferred.
- Demonstrated ability to assess risk and independently make decisions
- Impeccable attention to detail
- Ability absorb rapidly shifting priorities while not losing site of lower priorities
- Proven negotiation skills
- Manage projects at all stages of the life cycle
- Demonstrated performance in meeting deadlines and delivering high quality projects
- Primary focus has been in QA and / or RA, but candidate has held other titles in other functions
- CMO experience preferred
- Bachelors Degree required

Principal Accountabilities:
- Review labeling to ensure regulatory requirements are met for various types of labeling including labeling for regulatory submissions and labeling for commercial products.
- Independently manage all aspects of labeling and packaging activities between Sagent and partners to ensure labeling is compliant with the regulations and ready for product launch.
- Ensure compliant change control system for product labeling is maintained.
- Proofread label copy at various stages including final label copy to ensure accurate labeling.
- Management the Drug Listing and Barcode assignment process.
- Incumbent has supervisory responsibility for (Sr.) Associates (3-5 people)

Location:	1901 North Roselle Road Suite 700 Schaumburg, IL 60195 United States