Quality Assurance & Quality Control, Quality/Risk Management, Research & Development, US Regulatory Affairs
4 Year Degree
Keep abreast of current regulatory requirements and provide regulatory advice
Lead the preparation and timely submission of regulatory filings, maintain existing products up to regulatory standards and plan for life cycle management
Manage, review and write regulatory submissions electronically which include New ANDA filings, Complete Response Letters, Information Requests, Amendments to the ANDA’s (Labeling, Chemistry & Bio-equivalence) of different dosage forms (Oral Solids and Solution).
Lead or assist filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS).
Review the change controls for the regulatory requirements and make sure that they are in-line with appropriate regulations and guidance suggested by USFDA to maintain the safety and efficacy of the drug product.
Prepare PADER (Periodic adverse drug experience report) and safety issues reports for the marketed drug product based on the market feedback and complaints if any.It involves the knowledge on Pharmaco Vigilance requirements and procedures of periodic reporting.
Prepare and submit labeling for ANDA submissions which includes initiating artwork and prepare SPL for PIs using labeling software
Should be familiar with annual establishment registrations, drug listings and SPL submissions.
Prepare XML files using ECTD software according to the FDA guidelines for ECTD submissions.
The position requires a minimum of a bachelor’s degree or equivalent education in Pharmacy, Chemistry or a closely related field but advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.) preferred
Experience in the pharmaceutical industry (3-5 years)
A proven track record of effective collaboration with regulatory agencies, including the FDA
Excellent verbal and written communication skills
Internal Number: 1
About Sunrise Pharmaceutical, Inc.
Sunrise Pharma is a premier provider of high quality, affordable generic medicines. Sunrise is a rapidly growing developer and manufacturer of generics founded and based in the United States. Our products appear in various dosage forms across multiple therapeutic areas. We market products to all pharmaceutical channels including local and national retailers, wholesalers, distributors, health systems, and government.
We understand the role of medicine in our society and we are wholly committed to supplying top notch quality products to the US pharmaceutical market. Our aim is to provide a diverse portfolio of safe and affordable generic medications to millions of patients to lead a happier and healthier life.