Manager, Regulatory Affairs Sagent Pharmaceuticals

Basic Function:

The Manager of Regulatory Affairs is responsible for the development of new product filings to FDA and registration maintenance under the direction of the VP of Regulatory Affairs.


Education/Work Experience:
- Bachelors or advanced degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering or equivalent.
- 2-5 years healthcare experience.
- Direct Regulatory Affairs experience preferable.


Principal Accountabilities:
- Preparation and review of dossiers for FDA submission including ANDA?s, 505(b)(2)?s, DMF?s and 510(k)?s in line with regulatory requirements, regulatory guidelines, and GMP compliance.
- Coordinate efforts to answer deficiency letters, including establishing regulatory strategies, advising on data requirements, and preparing responses.
- Identify, assist with gathering, and evaluate data from partners as needed to support submissions.
- Prepare documentation needed to maintain registration of products (Supplements, Annual Reports, DMF updates and Labeling changes).
- Administers change control process by reviewing proposed changes against most recent applicable filings to ensure regulations, guidelines, and commitments are satisfied.
- Review labeling, advertising, promotional materials, study protocols, validation protocols to ensure compliance with applicable regulations and existing regulatory filings.
- Manage up to 3 subordinates.
- 10%-20% domestic and international travel.


Specific Technical/Job-Related Skills:
- Possess strong organizational skills for prioritizing workload and responsibilities.
- Strong written communication, interpersonal, negotiations and problem solving skills are required.
- Proficient with PC-based word processors, databases and spreadsheets.

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